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

NCT ID: NCT06609161

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2024-08-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tedizolid Phosphate Oral Formulation 1 (Reference)

Participants will receive oral Formulation 1 (Reference).

Group Type EXPERIMENTAL

Tedizolid Phosphate Oral Formulation 1 (Reference)

Intervention Type DRUG

Formulation 1 (FM1) powder for oral suspension.

Tedizolid Phosphate Oral Formulation 2 (Test)

Participants will receive oral Formulation 2 (Test).

Group Type EXPERIMENTAL

Tedizolid Phosphate Oral Formulation 2 (Test)

Intervention Type DRUG

Formulation 2 (FM2) powder for oral suspension.

Interventions

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Tedizolid Phosphate Oral Formulation 1 (Reference)

Formulation 1 (FM1) powder for oral suspension.

Intervention Type DRUG

Tedizolid Phosphate Oral Formulation 2 (Test)

Formulation 2 (FM2) powder for oral suspension.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Celerion (Site 0001)

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-1986-044

Identifier Type: OTHER

Identifier Source: secondary_id

1986-044

Identifier Type: -

Identifier Source: org_study_id

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