臨床研究等提出・公開システム

Scientific Title	Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1708 in Healthy Japanese Participants
Public Title	Single and Multiple Dose Study of MK-1708 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@merck.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@merck.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 04, 2024
Actual date of first enrollment		Aug. 24, 2024
Target sample size		64
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 participants and female participants of nonchildbearing potential 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		Alzheimer's disease, Amyotrophic lateral sclerosis
Intervention(s)		In Part 1, a single oral dose of MK-1708 1.8, 5, 10, 20 mg, or placebo will be administered. In Part 2, multiple oral doses of MK-1708 10 mg or less or placebo will be administered once daily for 12 days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety (Adverse Events, Discontinuations due to Adverse Events)
Secondary Outcome(s)		Pharmacokinetics (Evaluation of plasma pharmacokinetics, comparison of plasma pharmacokinetics among CYP2C19 phenotypes)

Primary Sponsor	MSD K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku,Fukuoka, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Aug. 01, 2024

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

Secondary ID(s)	NA
Issuing Authority	NA

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 02, 2024	(this page)	Changes
1	July. 20, 2024	Detail

List of change history