A Mass Balance Study of [14C]DS-1001b
Completed
- Conditions
- Healthy adult male
- Registration Number
- jRCT2071240033
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Subjects who meet all of the following criteria are eligible for the study.
- Healthy Japanese adult males
- Aged 18 to 55 years (both inclusive) at the time of informed consent
- A body mass index (BMI) >=18.5 and <25.0 kg/m^2 at the time of screening test
- UGT1A1 EM (having no mutation of *6 and *28), or UGT1A1 PM (having either of *6/*6, *6/*28, or *28/*28)
Exclusion Criteria
- 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)
- 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
- Having a history of hypersensitivity or being idiosyncratic (e.g., having penicillin allergy) to any drug
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - Mass balance and pharmacokinetics
- Secondary Outcome Measures
Name Time Method