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

NCT06816030 | Completed Phase 1 FDA Drug

• 2 other identifiers: 4482-009MK-4482-009
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (17)

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

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

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

  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.

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

• 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

  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.

  At designated time points up to 72 hours post-dose

• 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

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

  At designated time points up to 72 hours post-dose

• 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

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

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

  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.

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

• 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

  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.

  At designated time points up to 72 hours post-dose

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

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

  At designated time points up to 72 hours post-dose

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

  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.

  At designated time points up to 72 hours post-dose

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

  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.

  At designated time points up to 72 hours post-dose

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to ~ 5.5 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to ~ 5.5 weeks

Study Arms (1)

MK-4482

EXPERIMENTAL

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.

Drug: MK-4482

Interventions

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.

MK-4482

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Healthy male adult participants of Chinese descent
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Zhu J, Zhang D, Liu Z, Yan B, Zang Y, Zhao W, Sun F, Maas BM, Cheng MH, Stoch SA, Li H. Pharmacokinetics and Safety of Single and Multiple Doses of Molnupiravir in Healthy Male Chinese Adults: An Open-Label, Fixed Sequence, Phase 1 Study. Clin Transl Sci. 2026 Apr;19(4):e70481. doi: 10.1111/cts.70481.

  PMID: 41904711 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential model

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: June 28, 2023
• Primary Completion: August 5, 2023
• Study Completion: August 5, 2023
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)