臨床研究等提出・公開システム

Date of registration	Aug. 06, 2021
Last modified on	Jan. 08, 2022
Trial ID	jRCT2031210233

Scientific Title	A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-0616 in Healthy Japanese Participants.
Public Title	Single and Multiple Dose Study of MK-0616 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@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	Not Recruiting

Anticipated date of first enrollment		Aug. 22, 2021
Actual date of first enrollment		Sept. 04, 2021
Target sample size		48
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male participants and female participants of nonchildbearing potential between the ages of 20 and 45 years
	Exclusion Criteria	Has a history of clinically significant abnormalities or diseases
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hypercholesterolemia
Intervention(s)		-Palens A, B and C Single dose of MK-0616 5, 10, 20, 40, 100 or 200 mg, or matching placebo will be administerd in Periods 1 and 2, respectively. -Panel D Multiple doses of MK-0616 30 mg, or matching placebo will be administered once daily for 14 days.
Primary Outcome(s)		Safety (AEs, physical examination findings, laboratory safety assessments, 12-lead ECG, vital signs) and phaemacokinetics (Single Dose: AUC0-inf, AUC0-24, AUClast, Cmax, Tmax, C24, apparent terminal t1/2, CL/F and Vz/F, Multiple Dose: AUC0-24, Cmax, Tmax, C24, apparent terminal t1/2 and accumulation ratio)
Secondary Outcome(s)		Pharmacodynamics (Percentage of reduction of free PCSK9 from baseline, Free PCSK9 concentration, Percent reduction of LDL-C from baseline, LDL-C concentration)

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	July. 21, 2021

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

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 08, 2022	(this page)	Changes
2	Sept. 10, 2021	Detail	Changes
1	Aug. 06, 2021	Detail

List of change history