A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

NCT03217565 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 1986-014MK-1986-0142017-000953-38
• Study Type: interventional
• Target: 47
• Locations: 5 countries
• Sites: 30

Brief Summary

The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

Conditions

Gram-Positive Infections

Outcome Measures

Primary Outcomes (25)

• Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration

  AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of pharmacokinetic (PK) outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration

  AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration

  Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration

  Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration

  t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate t½ for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration

  AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-last for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration

  AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-inf for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration

  Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Cmax for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration

  Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Tmax for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration

  t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate t½ for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last]

  AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-last for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate

  AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate

  Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Cmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate

  Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Tmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate

  t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, t½ for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.

  1, 1.5, 3, 6, 12 and 24 hours post start of dosing

• Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last]

  AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate

  Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate

  Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate

  AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single concentration listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, AUC0-inf of tedizolid metabolite could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in single dose (Part A Group 1\[Cohorts 1 and 2\],Group 2 Cohort 1, Group 3 Cohort 1; Part B\[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate

  t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, t½ could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, t½ for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.

  Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

• Part B: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension [AUC0-last]

  AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-last for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.

  1, 3, 5, 8, 12, and 24 hours post start of dosing

• Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension

  AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-inf for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.

  1, 3, 5, 8, 12, and 24 hours post start of dosing

• Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension

  Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.

  1, 3, 5, 8, 12, and 24 hours post start of dosing

• Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension

  Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.

  1, 3, 5, 8, 12, and 24 hours post start of dosing

• Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension

  t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, t½ for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.

  1, 3, 5, 8, 12, and 24 hours post start of dosing

Secondary Outcomes (2)

• Number of Participants With an Adverse Event (AE)

  Up to approximately 21 days

• Number of Participants That Discontinued Study Treatment Due to an AE

  Up to approximately 3 days

Study Arms (9)

Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months

EXPERIMENTAL

Pediatric participants 28 days to \<6 months of age will receive a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: IV Tedizolid Phosphate

Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months

EXPERIMENTAL

Pediatric participants 6 months to \<24 months of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: IV Tedizolid Phosphate

Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days

EXPERIMENTAL

Full term (FT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: IV Tedizolid Phosphate

Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days

EXPERIMENTAL

FT neonates from birth to \<28 days of age will receive multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days.

Drug: IV Tedizolid Phosphate

Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days

EXPERIMENTAL

Preterm (PT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: IV Tedizolid Phosphate

Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days

EXPERIMENTAL

PT neonates from birth to \<28 days of age will receive MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days.

Drug: IV Tedizolid Phosphate

Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months

EXPERIMENTAL

Pediatric participants 28 days to \<24 months of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: Oral Suspension Tedizolid Phosphate

Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days

EXPERIMENTAL

FT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: Oral Suspension Tedizolid Phosphate

Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days

EXPERIMENTAL

PT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Drug: Oral Suspension Tedizolid Phosphate

Interventions

IV Tedizolid Phosphate DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months; Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months; Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days; Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days; Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days; Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days

Oral Suspension Tedizolid Phosphate DRUG

A single dose of tedizolid phosphate administered as an oral suspension.

Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months; Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days; Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity.
• Is at least 1 kg in weight.
• Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
• Has no clinically significant ECG abnormalities.
• Has sufficient vascular access to receive trial drug, and allow for required blood draws.
• Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable.

You may not qualify if:

• Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator.
• Has used rifampin within 14 days prior to dosing.
• Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing..
• Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease.
• Has a history of drug allergy or hypersensitivity to oxazolidinones.
• Has had significant blood loss.
• Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug.
• Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study.
• Has received another investigational product within the 30 days prior to enrollment.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (30)

Arkansas Children's Hospital ( Site 1012)

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital of Orange County ( Site 1001)

Orange, California, 92868, United States

Location

Sharp Memorial Hospital ( Site 1021)

San Diego, California, 92123, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022)

Chicago, Illinois, 60611, United States

Location

Our Lady of the Lake Regional Medical Center. ( Site 1004)

Baton Rouge, Louisiana, 70808, United States

Location

Saint Louis Children's Hospital ( Site 1020)

St Louis, Missouri, 63110, United States

Location

Primary Children's Hospital ( Site 1000)

Salt Lake City, Utah, 84113, United States

Location

Medical Center - 1- Sevlievo EOOD ( Site 2207)

Sevlievo, Gabrovo, 5400, Bulgaria

Location

MHAT Sv. Ivan Rilski EOOD ( Site 2201)

Kozloduy, Vratsa, 3320, Bulgaria

Location

UMHAT Deva Maria ( Site 2208)

Burgas, 8127, Bulgaria

Location

MHAT Dr. Tota Venkova-Pediatrics ( Site 2218)

Gabrovo, 5300, Bulgaria

Location

MHAT "Dr. Stamen Iliev" Montana ( Site 2215)

Montana, 3400, Bulgaria

Location

MHAT City Clinic Sv. Georgi EOOD ( Site 2202)

Montana, 3400, Bulgaria

Location

UMHAT Dr. Georgi Stranski EAD ( Site 2211)

Pleven, 5800, Bulgaria

Location

MHAT Rousse-Neonatology ( Site 2213)

Rousse, 7002, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Ruse ( Site 2204)

Rousse, 7002, Bulgaria

Location

UMHAT Kanev AD ( Site 2209)

Rousse, 7002, Bulgaria

Location

MHAT Dr. Ival Seliminski ( Site 2212)

Sliven, 8800, Bulgaria

Location

Hospital San Vicente Fundacion ( Site 1103)

Medellín, Antioquia, 050010, Colombia

Location

Clinica de la Costa S.A.S. ( Site 1106)

Barranquilla, Atlántico, 080020, Colombia

Location

Fundacion Hospital Infantil Universitario de San Jose ( Site 1107)

Bogotá, Bogota D.C., 111221, Colombia

Location

Fundacion Valle del Lili ( Site 1102)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Akershus Universitetssykehus HF ( Site 1604)

Loerenskog, Akershus, 1478, Norway

Location

Haukeland Universitetssjukehus ( Site 1602)

Bergen, Hordaland, 5021, Norway

Location

Stavanger Universitetssykehus, Helse Stavanger ( Site 1601)

Stavanger, Rogaland, 4011, Norway

Location

St. Olavs Hospital. ( Site 1600)

Trondheim, Sor-Trondelag, 7006, Norway

Location

University Hospital Southampton NHS Foundation Trust ( Site 1700)

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703)

Liverpool, Lancashire, L12 2AP, United Kingdom

Location

Royal Victoria Infirmary ( Site 1702)

Newcastle, Newcastle Upon Tyne, NE1 4LP, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust ( Site 1704)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

tedizolid phosphate

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: February 6, 2019
• Primary Completion: March 18, 2023
• Study Completion: April 6, 2023
• Last Updated: February 11, 2025
• Results First Posted: July 22, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (7); BU (11); GB (4); NO (4); CO (4)