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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06609161

Enrollment

Registered

2024-09-24

Start date

2024-07-16

Completion date

2024-08-08

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGTedizolid Phosphate Oral Formulation 1 (Reference)

Formulation 1 (FM1) powder for oral suspension.

DRUGTedizolid Phosphate Oral Formulation 2 (Test)

Formulation 2 (FM2) powder for oral suspension.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid	At designated time points (up to 3 days postdose)	Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid	At designated time points (up to 3 days postdose)	Blood samples will be collected to determine the AUC0-Last of tedizolid.
Maximum Plasma Concentration (Cmax) of Tedizolid	At designated time points (up to 3 days postdose)	Blood samples will be collected to determine the Cmax of tedizolid.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026