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

A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension

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.

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): 36
• 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:

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

Exclusion Criteria:

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

• 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)

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 receive tedizolid phosphate formulation 1 orally.	Drug: Tedizolid Phosphate Oral Formulation 1 (Reference); Oral administration; Other Names: TR-701 FA; MK-1986
Experimental: Tedizolid Phosphate Oral Formulation 2 (Test); Participants receive tedizolid phosphate formulation 2 orally.	Drug: Tedizolid Phosphate Oral Formulation 2 (Test); Oral administration; Other Names: TR-701 FA; MK-1986

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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 After Nonintravenous Administration (Vd/F)	Blood samples will be collected to determine the Vd/F of tedizolid.	At designated time points (up to 3 days postdose)
Oral 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)
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	Up to approximately 2 weeks
Number of Participants Who Discontinue Study Due to an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	Up to approximately 2 weeks

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): March 23, 2022
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Oxazolidinones; Tedizolid; Tedizolid phosphate
• Other Study ID Numbers: 1986-043; MK-1986-043 (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