臨床研究等提出・公開システム

Date of registration	July. 30, 2021
Last modified on	Jan. 11, 2023
Trial ID	jRCT2031210214

Scientific Title	A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1942 in Healthy Japanese Adult Participants
Public Title	Single and Multiple Dose Study of MK-1942 in Healthy Japanese Adults

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	inquiry mailbox MSDJRCT
	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		Aug. 02, 2021
Actual date of first enrollment		Aug. 02, 2021
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 aged 20 to 45 years old with BMI 18.5 to 25.0 kg/m2
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Alzheimer's Disease, Treatment-Resistant Depression
Intervention(s)		Single dose administration of MK-1942 (4, 8 or 10 mg) in the fasted state, single dose administration of MK-1942 (4 mg) in the fed state or multiple dose administration for 28 days of MK-1942 (8, 15, 30 and 50 mg BID for 7 days in each dose)
Primary Outcome(s)		Part 1 (Single dose): -Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations, neurological exams Part 2 (Multiple dose): -Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations, neurological exams, Columbia suicide severity rating scale
Secondary Outcome(s)		Part 1 (Single dose): -AUC0-inf, Cmax, Tmax, apparent terminal t1/2, CL/F and Vz/F in the fasted state -AUC0-inf and Cmax in the fasted and fed state -AUC0-inf and Cmax in the fasted state between healthy Japanese participants with a CYP2C19 extensive metabolizer and poor metabolizer phenotype. Part 2 (Multiple dose): -Day 1: AUC0-12, Cmax, Tmax, Ctrough -Days 7, 14, 21 and 28: AUC0-12, Cmax, Tmax, Ctrough, apparent terminal t1/2, CL/F, Vz/F, accumulation ratios* * Following last dose only ** Day 7 only

Primary Sponsor	MSD K.K.

Name of Certified Review Board	P-One Clinic, Keikokai Medical Corp. 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	July. 21, 2021

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
4	Jan. 11, 2023	(this page)	Changes
3	Dec. 25, 2021	Detail	Changes
2	Aug. 31, 2021	Detail	Changes
1	July. 30, 2021	Detail

List of change history