臨床研究等提出・公開システム

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

A Mass Balance Study of [14C]DS-1001b

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

Aug. 07, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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)

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)

Male

Healthy adult male

Administer a single oral dose of suspension of DS-1001b containing [14C]DS-1001b to the subjects in the fasted state.

Mass balance and pharmacokinetics

Pharmacokinetics of parent drug and its metabolite, safety

+81-92-283-7701

July. 11, 2024

No

none