臨床研究等提出・公開システム

Date of registration	May. 10, 2021
Last modified on	Aug. 31, 2021
Trial ID	jRCT2031210073

Scientific Title	A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-5475 in Healthy Japanese and Caucasian Participants
Public Title	Single and Multiple Dose Study of MK-5475 in Healthy 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		May. 25, 2021
Actual date of first enrollment		May. 26, 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 Japanese or Caucasian male participants between the ages of 20 and 45 years (inclusive) with a BMI less than or equal to 30 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		Pulmonary Hypertension
Intervention(s)		-Part 1 (Single dose part) Single inhaled dose of MK-5475 32, 100 and 380 ug, or matching placebo will be administerd in period 1, 2 and 3 respectively. -Part 2 (Multiple dose part) Multiple inhaled doses of MK-5475 100 or 380 ug, or matching placebo will be administered once daily for 7 days.
Primary Outcome(s)		-Part 1 (Single dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants -Part 2 (Multiple dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
Secondary Outcome(s)		-Part 1 (Single dose part) AUC0-inf, Cmax, AUC0-24, Tmax and t1/2 following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants -Part 2 (Multiple dose part) AUC0-inf, Cmax, AUC0-24, Tmax, t1/2 and accumulation ratio based on Cmax and AUC0-24 following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants

Primary Sponsor	MSD K.K.

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies IRB
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-5213-0028
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval	May. 14, 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	Aug. 31, 2021	(this page)	Changes
3	Aug. 11, 2021	Detail	Changes
2	May. 28, 2021	Detail	Changes
1	May. 10, 2021	Detail

List of change history