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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06733688

1986-043

MK-1986-043 (Other Identifier)

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

Enrollment: 36 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Tedizolid Phosphate Oral Formulation 1 (Reference)

Experimental group

Description:

Participants receive tedizolid phosphate formulation 1 orally.

Treatment:

Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)

Tedizolid Phosphate Oral Formulation 2 (Test)

Experimental group

Description:

Participants receive tedizolid phosphate formulation 2 orally.

Treatment:

Drug: Tedizolid Phosphate Oral Formulation 2 (Test)