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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tedizolid Phosphate Oral Formulation 1 (Reference); Drug: Tedizolid Phosphate Oral Formulation 2 (Test)

• Registration Number: NCT06733688
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-03-23
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tedizolid Phosphate Oral Formulation 1 (Reference)	Tedizolid Phosphate Oral Formulation 1 (Reference)	Participants receive tedizolid phosphate formulation 1 orally.
Tedizolid Phosphate Oral Formulation 2 (Test)	Tedizolid Phosphate Oral Formulation 2 (Test)	Participants receive tedizolid phosphate formulation 2 orally.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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 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.

Trial Locations

Locations (1)

Celerion (Site 0001); 🇺🇸 Lincoln, Nebraska, United States