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

NCT ID: NCT06733688

Last Updated: 2024-12-13

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2022-04-15

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 absorption and elimination of different oral formulations from the healthy person's 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 receive tedizolid phosphate formulation 1 orally.

Group Type EXPERIMENTAL

Tedizolid Phosphate Oral Formulation 1 (Reference)

Intervention Type DRUG

Oral administration

Tedizolid Phosphate Oral Formulation 2 (Test)

Participants receive tedizolid phosphate formulation 2 orally.

Group Type EXPERIMENTAL

Tedizolid Phosphate Oral Formulation 2 (Test)

Intervention Type DRUG

Oral administration

Interventions

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Tedizolid Phosphate Oral Formulation 1 (Reference)

Oral administration

Intervention Type DRUG

Tedizolid Phosphate Oral Formulation 2 (Test)

Oral administration

Intervention Type DRUG

Other Intervention Names

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MK-1986 TR-701 FA MK-1986 TR-701 FA

Eligibility Criteria

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Inclusion Criteria

* Is in good health before randomization
* Has a body mass index (BMI) ≥18.5 and ≤34 kg/m\^2, inclusive

Exclusion Criteria

* 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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 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-1986-043

Identifier Type: OTHER

Identifier Source: secondary_id

1986-043

Identifier Type: -

Identifier Source: org_study_id