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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tedizolid Phosphate Oral Formulation 1 (Reference); Drug: Tedizolid Phosphate Oral Formulation 2 (Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06609161

MK-1986-044 (Other Identifier)

1986-044

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Tedizolid Phosphate Oral Formulation 1 (Reference)

Experimental group

Description:

Participants will receive oral Formulation 1 (Reference).

Treatment:

Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test)

Experimental group

Description:

Participants will receive oral Formulation 2 (Test).

Treatment:

Drug: Tedizolid Phosphate Oral Formulation 2 (Test)