Multiple Dose Study of MK-6024 in Healthy Japanese Participants

JRCT ID: jRCT2031210703

Registered date:26/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nonalcoholic steatohepatitis
• Date of first enrollment: 21/04/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The participants will receive multiple SC doses of MK-6024 or matching placebo for total 16 weeks (MK-6024 2.4, 5, 7.4 and 10 mg, or placebo for every 4 week).

Outcome(s)

• Primary Outcome: AEs and AEs leading to discontinuation

Secondary Outcome

Following serum PK parameters
-Following 4th, 8th, 12th and last (16th) doses: Tmax, Cmax, AUC0-tau
-Following 16th dose: t1/2, CL/F, Vz/F
-Following 3rd, 4th, 7th, 8th, 11th to 16th doses: Ctrough

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Male
• Include criteria: Healthy male aged 20 to 65 years old with BMI 23 to 40 kg/m2
• Exclude criteria: Has a history of clinically significant abnormalities or diseases

Related Information

• Primary Sponsor: Yoshiyuki Tanaka