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Completed

NCT Number: NCT06816030

A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)

The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it.

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Key information

Conditions

Healthy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit.

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant abnormalities or diseases.
  • Has history of cancer.
  • Has a history of significant multiple and/or severe allergies.
  • Had any major surgery.
  • Has participated in another investigational study within 3 months prior to the screening visit.

Treatment and study plan

MK-4482

Drug

Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.

Primary outcomes

  1. The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.

    Time frame: At designated time points up to 72 hours post-dose

    Tmax of NHC following single oral dose of MK-4482 in period 1.

  3. Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.

  4. Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.

  5. Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.

  6. Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.

  7. Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    AUC0-last of NHC following a single oral dose of MK-4482 in period 1.

  8. Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1

    Time frame: At designated time points up to 72 hours post-dose

    AUC0-inf of NHC after single oral dose of MK-4482 in period 1.

  9. The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    Cmax of NHC after multiple oral doses of MK-4482 in period 2.

  10. Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    Tmax of NHC following multiple oral doses of MK-4482 in period 2.

  11. Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.

  12. Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.

  13. Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.

  14. Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.

  15. The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.

  16. Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2

    Time frame: At designated time points up to 72 hours post-dose

    The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.

  17. Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482

    Time frame: At designated time points up to 72 hours post-dose

    The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.

Secondary outcomes

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

    Time frame: Up to ~ 5.5 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. The number of participants who experience an AE will be reported.

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

    Time frame: Up to ~ 5.5 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. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of MK-4482 in Chinese Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2025
Registry last updated
Apr 16, 2026

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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