臨床研究等提出・公開システム

Date of registration	Oct. 16, 2023
Last modified on	Sept. 20, 2024
Trial ID	jRCT2031230399

Scientific Title	A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1167 in Healthy Japanese Participants
Public Title	Single and Multiple Dose Study of MK-1167 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		Oct. 24, 2023
Actual date of first enrollment		Oct. 24, 2023
Target sample size		56
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 Japanese males or postmenopausal females aged 18 to 45 years old
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dementia Alzheimer's type
Intervention(s)		In Part 1, a single oral dose of MK-1167 3, 12 or 25 mg, or placebo will be administered. In Part 2, multiple oral doses of MK-1167 or placebo will be administered at the dose level of 22 mg on Days 1-2 and 5 mg on Days 3-10.
Primary Outcome(s)		Safety
Secondary Outcome(s)		Pharmacokinetics (Evaluation of plasma pharmacokinetics, comparison of plasma pharmacokinetics among CYP2C19 phenotypes)

Primary Sponsor	MSD K.K.

Name of Certified Review Board	Institutional Review Board, P-One Clinic, Keikokai Medical Corporation
Address	View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City,Tokyo, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@keikokai-gr.or.jp
Approval Status	Approval
Date of approval	Oct. 05, 2023

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

Secondary ID(s)	N/A
Issuing Authority	N/A

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 20, 2024	(this page)	Changes
3	May. 30, 2024	Detail	Changes
2	Nov. 03, 2023	Detail	Changes
1	Oct. 16, 2023	Detail

List of change history