A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)

NCT06733688 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1986-043MK-1986-043
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the absorption and elimination of different oral formulations from the healthy person's body.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid

  Blood samples will be collected to determine the AUC0-Inf of tedizolid.

  At designated time points (up to 3 days postdose)

• Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) of Tedizolid

  Blood samples will be collected to determine the AUC0-t of tedizolid.

  At designated time points (up to 3 days postdose)

• Maximum Plasma Concentration (Cmax) of Tedizolid

  Blood samples will be collected to determine the Cmax of tedizolid.

  At designated time points (up to 3 days postdose)

Secondary Outcomes (6)

• Time to Maximum Plasma Concentration (Tmax) of Tedizolid

  At designated time points (up to 3 days postdose)

• Apparent Terminal Half-Life (t1/2) of Tedizolid

  At designated time points (up to 3 days postdose)

• Apparent Volume of Distribution of Tedizolid After Nonintravenous Administration (Vd/F)

  At designated time points (up to 3 days postdose)

• Oral Clearance (CL/F) of Tedizolid

  At designated time points (up to 3 days postdose)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 2 weeks

Study Arms (2)

Tedizolid Phosphate Oral Formulation 1 (Reference)

EXPERIMENTAL

Participants receive tedizolid phosphate formulation 1 orally.

Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test)

EXPERIMENTAL

Participants receive tedizolid phosphate formulation 2 orally.

Drug: Tedizolid Phosphate Oral Formulation 2 (Test)

Interventions

Tedizolid Phosphate Oral Formulation 1 (Reference) DRUG

Oral administration

Also known as: MK-1986, TR-701 FA

Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test) DRUG

Oral administration

Also known as: MK-1986, TR-701 FA

Tedizolid Phosphate Oral Formulation 2 (Test)

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18.5 and ≤34 kg/m\^2, inclusive

You may not qualify if:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of clinically significant cancer (malignancy)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: March 23, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)