臨床研究等提出・公開システム

Date of registration	Feb. 23, 2023
Last modified on	April. 26, 2024
Trial ID	jRCT2031220658

Scientific Title	A Single-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Japanese Participants
Public Title	Single Dose Study of MK-2060 in Healthy Japanese Participants

Contact for Scientific Queries	Name	Tanaka Yoshiyuki
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com
Contact for Public Queries	Name	MSDJRCT inquiry mailbox
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 27, 2023
Actual date of first enrollment		Mar. 27, 2023
Target sample size		48
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male or female aged 18 to 50 years old with BMI 18 to 32 kg/m2
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	18age old over
	Age Maximum	50age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of thrombotic vascular events
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.
Primary Outcome(s)		Adverse Events
Secondary Outcome(s)		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

Primary Sponsor	MSD K.K.

Name of Certified Review Board	Houeikai Institutional Review Board
Address	3-28-3, Ikebukuro, Toshima-ku, Tokyo
Telephone	+81-3-5396-4530
Approval Status	Approval
Date of approval	Feb. 10, 2023

Plan to share IPD	Yes
Plan description	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 26, 2024	(this page)	Changes
5	Mar. 15, 2024	Detail	Changes
4	Oct. 12, 2023	Detail	Changes
3	July. 07, 2023	Detail	Changes
2	April. 07, 2023	Detail	Changes
1	Feb. 23, 2023	Detail

List of change history