Skip to main content
OpenTrials
Completed

NCT Number: NCT06609161

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tedizolid Phosphate Oral Formulation 1 (Reference)

Drug

Formulation 1 (FM1) powder for oral suspension.

Tedizolid Phosphate Oral Formulation 2 (Test)

Drug

Formulation 2 (FM2) powder for oral suspension.

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the AUC0-Inf of tedizolid.

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the AUC0-Last of tedizolid.

  3. Maximum Plasma Concentration (Cmax) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the Cmax of tedizolid.

Secondary outcomes

  1. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to approximately 2 weeks postdose

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

  2. Number of Participants Who Discontinue Study Drug Due to an AE

    Time frame: Up to approximately 2 weeks postdose

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

  3. Time to Maximum Plasma Concentration (Tmax) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the Tmax of tedizolid.

  4. Apparent Terminal Half-Life (t1/2) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the t1/2 of tedizolid.

  5. Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the Vz/F of tedizolid.

  6. Apparent Clearance (CL/F) of Tedizolid

    Time frame: At designated time points (up to 3 days postdose)

    Blood samples will be collected to determine the CL/F of tedizolid.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.