Single and Multiple Dose Study of MK-0616 in Healthy Japanese Participants

A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-0616 in Healthy Japanese Participants.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210233

Enrollment

Registered

2021-08-06

Start date

2021-09-04

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

Hypercholesterolemia

Interventions

-Palens A, B and C Single dose of MK-0616 5, 10, 20, 40, 100 or 200 mg, or matching placebo will be administerd in Periods 1 and 2, respectively. -Panel D Multiple doses of MK-0616 30 mg, or matching

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male participants and female participants of nonchildbearing potential between the ages of 20 and 45 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety (AEs, physical examination findings, laboratory safety assessments, 12-lead ECG, vital signs) and phaemacokinetics (Single Dose: AUC0-inf, AUC0-24, AUClast, Cmax, Tmax, C24, apparent terminal t1/2, CL/F and Vz/F, Multiple Dose: AUC0-24, Cmax, Tmax, C24, apparent terminal t1/2 and accumulation ratio)	—

Secondary

Measure	Time frame
Pharmacodynamics (Percentage of reduction of free PCSK9 from baseline, Free PCSK9 concentration, Percent reduction of LDL-C from baseline, LDL-C concentration)	—

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