臨床研究等提出・公開システム

Japanese

Date of registration	July. 14, 2024
Last modified on	Aug. 06, 2024
Trial ID	jRCT2071240033

Scientific Title	A Phase I Open-Label Study to Evaluate the Mass Balance and Pharmacokinetics of [14C]DS-1001b Following Single Oral Administration to Healthy Adult Male Subjects
Public Title	A Mass Balance Study of [14C]DS-1001b

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 07, 2024
Actual date of first enrollment
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who meet all of the following criteria are eligible for the study. 1. Healthy Japanese adult males 2. Aged 18 to 55 years (both inclusive) at the time of informed consent 3. A body mass index (BMI) >=18.5 and <25.0 kg/m^2 at the time of screening test 4. UGT1A1 EM (having no mutation of 6 and 28), or UGT1A1 PM (having either of 6/6, 6/28, or 28/28)
	Exclusion Criteria	1. Having a history of stomach or intestinal surgery or disease that would potentially alter absorption and/or excretion of orally administered drugs (however, appendectomy and repair of pyloric stenosis are allowed) 2. Having 3 days or less with at least one spontaneous defecation (bowel movement without purgative medicine, enema or stool extraction) during the 7 days prior to the screening test 3. Having a history of hypersensitivity or being idiosyncratic (e.g., having penicillin allergy) to any drug 4. Underwent administration of radiolabeled substances or exposure to diagnostic/therapeutic radiation (e.g., gastric X ray, computed tomography [CT] scans, positron emission tomography [PET], etc.) during the period from 12 months before study drug administration and until completion of the post-study examination or follow-up examination (however, chest X ray and dental radiography are allowed)
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy adult male
Intervention(s)		Administer a single oral dose of suspension of DS-1001b containing [14C]DS-1001b to the subjects in the fasted state.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Mass balance and pharmacokinetics
Secondary Outcome(s)		Pharmacokinetics of parent drug and its metabolite, safety

Primary Sponsor	Daiichi Sankyo Co., Ltd.

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-shi, Fukuoka
Telephone	+81-92-283-7701
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 06, 2024	(this page)	Changes
2	July. 31, 2024	Detail	Changes
1	July. 14, 2024	Detail

List of change history