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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06733688

Enrollment

Registered

2024-12-13

Start date

2022-03-23

Completion date

2022-04-15

Last updated

2024-12-13

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 absorption and elimination of different oral formulations from the healthy person's body.

Interventions

DRUGTedizolid Phosphate Oral Formulation 1 (Reference)

Oral administration

DRUGTedizolid Phosphate Oral Formulation 2 (Test)

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

Yes

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

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 the Last Measurable Concentration (AUC0-t) of Tedizolid	At designated time points (up to 3 days postdose)	Blood samples will be collected to determine the AUC0-t 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
Oral 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 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 Discontinue Study Due to an AE	Up to approximately 2 weeks	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.
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 2 weeks	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.
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.
Apparent Volume of Distribution of Tedizolid After Nonintravenous Administration (Vd/F)	At designated time points (up to 3 days postdose)	Blood samples will be collected to determine the Vd/F of tedizolid.

Countries

United States

Outcome results

None listed

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