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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MK-4482

Study type: Interventional

Funder types: Industry

Identifiers

NCT06816030

MK-4482-009 (Other Identifier)

4482-009

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MK-4482

Experimental group

Description:

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.

Treatment:

Drug: MK-4482