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

Phase 1

• Conditions: Hypercholesterolemia

• Registration Number: JPRN-jRCT2031210233
• Lead Sponsor: Tanaka Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

Has a history of clinically significant abnormalities or diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacodynamics (Percentage of reduction of free PCSK9 from baseline, Free PCSK9 concentration, Percent reduction of LDL-C from baseline, LDL-C concentration)