A Study of PF-07258669 In Healthy Adult Participants

NCT05113940 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C45410032021-004037-36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to healthy adult participants. Optional cohorts of healthy adult Japanese participants and/or older adult participants may also be evaluated if results in other cohorts support further evaluation. Part B of this study is a 2-period, fixed-sequence, multiple-dose, open-label design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants. Part B will be conducted if the results of Part A support further evaluation of PF-07258669.

Conditions

Healthy Participants

Keywords

PF-07258669; multiple dose; melanocortin-4 receptor; MC4R; healthy participants; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (22)

• Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment.

  Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)

• Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality

  Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (\<) 0.8\* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (\>) 1.2\* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (\>) 3.0\* ULN for alanine aminotransferase, \>1.3\* ULN for urea nitrogen, cholesterol, and triglycerides; \>1.030 for specific gravity (scalar), greater than or equal to (\>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase.

  Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)

• Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data

  Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (\>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) \>= 20 mmHg, standing systolic SBP (mmHg) less than (\<) 90 mmHg, \>= 160 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) \< 50 mmHg, \>= 90 mmHg, change \>= 20 mmHg increase, change \>= 20mmHg decrease; postural difference (supine standing) \>= 10 mmHg; standing \<50 mmHg, value \>=90 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease, C) standing pulse rate (PR) greater than (\>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1.

  Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)

• Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria

  ECG criteria: QTc corrected using Fridericia's formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (\<=) change \<= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1.

  Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)

• Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening

  C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.

  Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])

• Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2

  C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.

  Part A: On Day -2 (2 days prior to dosing)

• Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7

  C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.

  Part A: On Day 7

• Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14

  C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.

  Part A: Day 14

• Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21

  C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.

  Part A: Day 21

• Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening

  All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.

  Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])

• Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1

  All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.

  Part A: Day -1 (1 day prior to dosing)

• Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7

  All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.

  Part A: Day 7

• Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14

  All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.

  Part A: Day 14

• Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1

  Cmax was defined as the maximum observed plasma concentration.

  Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1

• Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2

  Cmax is the maximum observed plasma concentration.

  Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2

• Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2

  Cmax was defined as the maximum observed plasma concentration.

  Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10

• Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1

  AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

  Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1

• Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2

  AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

  Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2

• Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2

  AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

  Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10

• Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1

  AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.

  Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1

• Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2

  AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.

  Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2

• Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2

  AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.

  Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10

Secondary Outcomes (12)

• Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14

  Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14

• Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14

  Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14

• Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14

  Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14

• Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14

  Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14

• Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14

  Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14

Study Arms (13)

PF-07258669 and Placebo (Cohort 1)

EXPERIMENTAL

Dose level 1: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Carbohydrate High Calorie (HCHC)

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 2)

EXPERIMENTAL

Dose level 2: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: HCHC

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 3)

EXPERIMENTAL

Dose level 3: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: HCHC

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 4)

EXPERIMENTAL

Dose level 4: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: Standard Diet (SD)

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 5)

EXPERIMENTAL

Dose level 5: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 6)

EXPERIMENTAL

Multiple dose administration of PF-07258669 and placebo over 14 days in Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

Midazolam with and without PF-07258669 (Cohort 8)

EXPERIMENTAL

Drug-drug interaction assessment of pharmacokinetics interaction in PF-07258669 and midazolam Dietary allocation: SD

Drug: PF-07258669; Drug: Midazolam

PF-07258669 and Placebo (Cohort 7)

EXPERIMENTAL

Multiple dose administration of PF-07258669 and placebo over 14 days in older adult participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 9)

EXPERIMENTAL

Dose level 6: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 10)

EXPERIMENTAL

Dose level 7: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 11)

EXPERIMENTAL

Dose level 8: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: SD

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 12)

EXPERIMENTAL

Dose Level 9: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Fat High Calorie (HFHC)

Drug: PF-07258669; Drug: Placebo

PF-07258669 and Placebo (Cohort 13)

EXPERIMENTAL

Dose Level 10: Multiple dose administration of PF-07258669 and placebo over 14 days in non-Japanese participants; 8 participants will receive PF-07258669 and 2 will receive placebo Dietary allocation: High Fat High Calorie (HFHC)

Drug: PF-07258669; Drug: Placebo

Interventions

PF-07258669 DRUG

PF-07258669 will be administered as tablets; every 8 hour (Q8H) or every 12 hour (Q12H) over 14 days

Midazolam with and without PF-07258669 (Cohort 8); PF-07258669 and Placebo (Cohort 1); PF-07258669 and Placebo (Cohort 10); PF-07258669 and Placebo (Cohort 11); PF-07258669 and Placebo (Cohort 12); PF-07258669 and Placebo (Cohort 13); PF-07258669 and Placebo (Cohort 2); PF-07258669 and Placebo (Cohort 3); PF-07258669 and Placebo (Cohort 4); PF-07258669 and Placebo (Cohort 5); PF-07258669 and Placebo (Cohort 6); PF-07258669 and Placebo (Cohort 7); PF-07258669 and Placebo (Cohort 9)

Placebo DRUG

Placebo will be administered as tablets; Q8H or Q12H over 14 days

PF-07258669 and Placebo (Cohort 1); PF-07258669 and Placebo (Cohort 10); PF-07258669 and Placebo (Cohort 11); PF-07258669 and Placebo (Cohort 12); PF-07258669 and Placebo (Cohort 13); PF-07258669 and Placebo (Cohort 2); PF-07258669 and Placebo (Cohort 3); PF-07258669 and Placebo (Cohort 4); PF-07258669 and Placebo (Cohort 5); PF-07258669 and Placebo (Cohort 6); PF-07258669 and Placebo (Cohort 7); PF-07258669 and Placebo (Cohort 9)

Midazolam DRUG

Single doses of Midazolam will be administered as oral solution alone and in combination with PF-07258669

Midazolam with and without PF-07258669 (Cohort 8)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For optional cohort of older adult participants only: Male participants and female participants of non childbearing potential must be 65 to 90 years of age, inclusive, at the time of signing the ICD (informed consent document). Attempts will be made to ensure that the age composition of this cohort (eg, approximately 70% of participants ≥70 years of age) is comparable to that of the anticipated patient population in later clinical studies.
• Female participants of nonchildbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• For optional cohort of older adult participants only: Participants must be in a stable condition at admission. These participants must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination, vital signs assessments, 12-lead ECG (electrocardiogram), and clinical laboratory tests. Participants with mild, chronic, stable disease (eg, controlled hypertension, noninsulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.
• Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor and to wear eye protection, as appropriate.
• Body mass index (BMI) of 17.5 to 28.5 kg/m2; and a total body weight \>50 kg (110 lb).
• For optional cohort of older adult participants only: BMI of 17.5 to 32.4 kg/m2; and a total body weight \>50 kg (110 lbs). Efforts will be made to enroll at least 3 older adult participants with BMI \<25 kg/m2, if feasible.
• Japanese participants only: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine (including, but not limited to, thyroid disease, diabetes insipidus), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including, but not limited to, primary polydipsia, obsessive compulsive disorder, anxiety disorder, schizophrenia), neurological (including, but not limited to, seizure disorder, traumatic brain injury), immunodeficiency (including, but not limited to, severe infection that required ICU admission, prolonged hospitalization, or prolonged treatment) or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of clinical laboratory abnormalities.
• For optional cohort of older adult participants only: Participants with chronic conditions (eg, hypertension) that are controlled by either diet or stable doses of medications may be included. Recent evidence (ie, within previous 6 months) or history of unstable disease or moderate to severe conditions which would, in the investigator's opinion, interfere with the study evaluations or have an impact on the safety of participants.
• History of symptomatic orthostatic hypotension or symptomatic bradycardia.
• History of eating disorders (eg, anorexia or bulimia nervosa, binge-eating disorder, avoidant/restrictive food intake disorder).
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• For optional cohort of older adult participants only: Participants taking daily prescription or non-prescription medications (that are not moderate or strong cytochrome P450 (CYP3A) inducers or inhibitors) for management of acceptable chronic medical conditions are to be on a stable dose, as defined by no change in dose for the 28 days or 5 half-lives (whichever is longer) before the screening visit.
• Use of stable concomitant mediations noted above that are CYP3A substrates may be restricted.
• All medications must be reviewed on a case-by-case basis by the investigator and approved by the sponsor during the screening period for eligibility purposes.
• Use of moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 28 days or 5 half-lives (whichever is longer) prior to first dose of study intervention.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• Fasting serum triglycerides \>2× ULN (upper limit of normal).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Any untoward findings identified on physical and/or neurological examinations, cardiac monitoring and pulse oximeter monitoring conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 9, 2021
• Study Start: November 8, 2021
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)