臨床研究等提出・公開システム

Scientific Title	A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-7480 in Healthy Japanese Participants
Public Title	Single and Multiple Dose Study of MK-7480 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	Pending

Anticipated date of first enrollment		July. 08, 2024
Actual date of first enrollment
Target sample size		36
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 females aged 18 to 55 years old
	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		Nonalcoholic fatty liver disease
Intervention(s)		In Part 1, a single oral dose of MK-7480 30, 90, 240, 300 mg or placebo will be administered. In Part 2, multiple oral doses of MK-7480 120 or 240 mg, or placebo will be administered once daily for 14 days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety
Secondary Outcome(s)		Pharmacokinetics

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
Date of approval

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

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none