Clinical trial NCT06816030: A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Coronavirus Disease (COVID-19)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential model
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1
timeFrame: At designated time points up to 72 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.
timeFrame: At designated time points up to 72 hours post-dose
measure: Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1
timeFrame: At designated time points up to 72 hours post-dose
measure: Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1
timeFrame: At designated time points up to 72 hours post-dose
measure: Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1
timeFrame: At designated time points up to 72 hours post-dose
measure: 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
timeFrame: At designated time points up to 72 hours post-dose
measure: 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
timeFrame: At designated time points up to 72 hours post-dose
measure: 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
timeFrame: At designated time points up to 72 hours post-dose
measure: The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: 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
timeFrame: At designated time points up to 72 hours post-dose
measure: The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2
timeFrame: At designated time points up to 72 hours post-dose
measure: Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482
timeFrame: At designated time points up to 72 hours post-dose
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 5.5 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~ 5.5 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital (Site 0001)
state: Beijing
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: