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

A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tedizolid Phosphate Oral Formulation 1 (Reference); Drug: Tedizolid Phosphate Oral Formulation 2 (Test)

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion (Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

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

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tedizolid Phosphate Oral Formulation 1 (Reference); Participants will receive oral Formulation 1 (Reference).	Drug: Tedizolid Phosphate Oral Formulation 1 (Reference); Formulation 1 (FM1) powder for oral suspension.
Experimental: Tedizolid Phosphate Oral Formulation 2 (Test); Participants will receive oral Formulation 2 (Test).	Drug: Tedizolid Phosphate Oral Formulation 2 (Test); Formulation 2 (FM2) powder for oral suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced an Adverse Event (AE)	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	Up to approximately 2 weeks postdose
Number of Participants Who Discontinue Study Drug Due to an AE	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	Up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of Tedizolid	Blood samples will be collected to determine the Tmax of tedizolid.	At designated time points (up to 3 days postdose)
Apparent Terminal Half-Life (t1/2) of Tedizolid	Blood samples will be collected to determine the t1/2 of tedizolid.	At designated time points (up to 3 days postdose)
Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)	Blood samples will be collected to determine the Vz/F of tedizolid.	At designated time points (up to 3 days postdose)
Apparent Clearance (CL/F) of Tedizolid	Blood samples will be collected to determine the CL/F of tedizolid.	At designated time points (up to 3 days postdose)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Oxazolidinones; Tedizolid; Tedizolid phosphate
• Other Study ID Numbers: 1986-044; MK-1986-044 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No