MK-0616 Pharmacokinetic study in Japanese and non-Japanese

An Open-label, Randomized, Single-dose, Crossover Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-0616 in Healthy Japanese, Chinese, and Caucasian Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220322

Enrollment

Registered

2022-09-08

Start date

2022-10-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesteremia

Interventions

In Periods 1 and 2, a single oral doses of MK-0616 18 mg is administered in the fasted state or with a meal 30 minutes after administration in crossover method. In Period 3, a single oral doses of MK-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Japanese, Chinese or Caucasian male participants and female participants of nonchildbearing potential between the ages of 25 and 65 years

Exclusion criteria

Exclusion criteria: Has a history of clinically significant abnormalities or diseases

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (Comparison between Japanese, Chinese and Caucasian)	—

Secondary

Measure	Time frame
- Safety (Adverse Events, Discontinuations due to Adverse Events) - Pharmacokinetics (Food effect)	—

Countries

Japan, United States of America

Contacts

Public ContactMSDJRCT inquiry mailbox

MSD K.K.

msdjrct@msd.com+81-3-6272-1957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026