臨床研究等提出・公開システム

Date of registration	Jan. 19, 2026
Last modified on	April. 06, 2026
Trial ID	jRCT2031250655

Scientific Title	A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Dose of MK-8507 and Multiple Once Weekly Dose of Islatravir/MK-8507 (MK-8591B) in Healthy Japanese Participants
Public Title	A Clinical Study of Islatravir/MK-8507 (MK-8591B) in Healthy Japanese Participants

Contact for Scientific Queries	Name	Yoshitsugu Hiroyuki
	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	Recruiting

Anticipated date of first enrollment		Mar. 26, 2026
Actual date of first enrollment		April. 03, 2026
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male and female participants between the ages of 18 and 55 years
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		HIV infection
Intervention(s)		Single dose of MK-8507 100, 200 and 400 mg or placebo Multiple weekly doses of MK-8591B (Islatravir/MK-8507) 2 mg/200 mg or placebo
Primary Outcome(s)		Safety (Adverse events, discontinuation of study intervention due to adverse events), Pharmacokinetics

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. 12, 2026

Plan to share IPD	Yes
Plan description	https://engagezone.msd.com/

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 06, 2026	(this page)	Changes
1	Jan. 19, 2026	Detail

List of change history