A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)

NCT06609161 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1986-044MK-1986-044
• Study Type: interventional
• Target: 18
• 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 oral formulations absorption and elimination from the healthy persons 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 Last (AUC0-Last) of Tedizolid

  Blood samples will be collected to determine the AUC0-Last 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)

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

  Up to approximately 2 weeks postdose

• Number of Participants Who Discontinue Study Drug Due to an AE

  Up to approximately 2 weeks postdose

• 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 During Terminal Phase (Vz/F)

  At designated time points (up to 3 days postdose)

Study Arms (2)

Tedizolid Phosphate Oral Formulation 1 (Reference)

EXPERIMENTAL

Participants will receive oral Formulation 1 (Reference).

Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test)

EXPERIMENTAL

Participants will receive oral Formulation 2 (Test).

Drug: Tedizolid Phosphate Oral Formulation 2 (Test)

Interventions

Tedizolid Phosphate Oral Formulation 1 (Reference) DRUG

Formulation 1 (FM1) powder for oral suspension.

Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test) DRUG

Formulation 2 (FM2) powder for oral suspension.

Tedizolid Phosphate Oral Formulation 2 (Test)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2

You may not qualify if:

• Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
• Has a history of clostridium difficile-associated diarrhea

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: September 20, 2024
• First Posted: September 24, 2024
• Study Start: July 16, 2024
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)