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Completed

NCT Number: NCT06733688

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

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.

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Key information

Conditions

Healthy

Age range

19 year–60 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:

  • 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)

Treatment and study plan

Tedizolid Phosphate Oral Formulation 1 (Reference)

Drug

Oral administration

Other names: MK-1986, TR-701 FA

Tedizolid Phosphate Oral Formulation 2 (Test)

Drug

Oral administration

Other names: MK-1986, TR-701 FA

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 the Last Measurable Concentration (AUC0-t) of Tedizolid

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

    Blood samples will be collected to determine the AUC0-t 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. 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.

  2. 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.

  3. Apparent Volume of Distribution of Tedizolid After Nonintravenous Administration (Vd/F)

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

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

  4. Oral 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.

  5. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  6. Number of Participants Who Discontinue Study Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2024
Registry last updated
Dec 13, 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.

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