Single Dose Study of MK-2060 in Healthy Japanese Participants

JRCT ID: jRCT2031220658

Registered date:23/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of thrombotic vascular events
• Date of first enrollment: 27/03/2023
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Single intravenous dose of MK-2060 8, 20 or 50 mg or matching placebo will be administerd. Or, single subctaneous dose of MK-2060 30 mg or matching placebo will be administerd.

Outcome(s)

• Primary Outcome: Adverse Events

Secondary Outcome

Following PK parameters and aPTT (activated partial thromboplastin time)
Intraveneous administration: AUC0-inf, AUC0-last, AUC0-168, Cmax, C168, Tmax, Tlast, t1/2, CL and Vz
Subctaneous administration: AUC0-inf, AUC0-last, AUC0-168, Cmax, C168, Tmax, Tlast, t1/2, CL/F and Vz/F

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both
• Include criteria: Healthy male or female aged 18 to 50 years old with BMI 18 to 32 kg/m2
• Exclude criteria: Has a history of clinically significant abnormalities or diseases

Related Information

• Primary Sponsor: Tanaka Yoshiyuki