臨床研究等提出・公開システム

Date of registration	Mar. 26, 2022
Last modified on	Feb. 21, 2023
Trial ID	jRCT2031210703

Scientific Title	A Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-6024 in Healthy Japanese Participants
Public Title	Multiple Dose Study of MK-6024 in Healthy Japanese Participants

Contact for Scientific Queries	Name	Yoshiyuki Tanaka
	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		April. 21, 2022
Actual date of first enrollment		April. 21, 2022
Target sample size		20
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 aged 20 to 65 years old with BMI 23 to 40 kg/m2
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	20age old over
	Age Maximum	65age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Nonalcoholic steatohepatitis
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).
Primary Outcome(s)		AEs and AEs leading to discontinuation
Secondary Outcome(s)		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

Primary Sponsor	MSD K.K.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	P-One Clinic, Keikokai Medical Corporation Institutional Review Board
Address	View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji-shi, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@keikokai-gr.or.jp
Approval Status	Approval
Date of approval	April. 08, 2022

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
2	Feb. 21, 2023	(this page)	Changes
1	Mar. 26, 2022	Detail

List of change history