臨床研究等提出・公開システム

Date of registration	April. 16, 2022
Last modified on	Feb. 21, 2023
Trial ID	jRCT2031220024

Scientific Title	A single-dose clinical study to evaluate the pharmacokinetics of belzutifan (MK-6482) in healthy Japanese female participants
Public Title	Single Dose Study of MK-6482 in Healthy Japanese Female 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		April. 29, 2022
Actual date of first enrollment		April. 21, 2022
Target sample size		24
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy female participants of nonchildbearing potential between the ages of 45 and 64 years
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	45age old over
	Age Maximum	64age old under
	Gender	Female
Health Condition(s) or Problem(s) Studied		Renal Cell Carcinoma
Intervention(s)		- Palens A and C Single dose of MK-6482 80 mg will be administerd. - Palens B and D Single dose of MK-6482 120 mg will be administerd.
Primary Outcome(s)		pharmacokinetics (Cmax, Tmax, AUC0-last, AUC0-inf, CL/F, Vz/F and t1/2)
Secondary Outcome(s)		Safety (Adverse events)

Primary Sponsor	MSD K.K.

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies IRB
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5213-0028
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval	April. 14, 2022

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

Secondary ID(s)	なし
Issuing Authority	none

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 21, 2023	(this page)	Changes
1	April. 16, 2022	Detail

List of change history