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

JRCT ID: jRCT2071240033

Registered date:14/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 08/08/2024
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Administer a single oral dose of suspension of DS-1001b containing [14C]DS-1001b to the subjects in the fasted state.

Outcome(s)

• Primary Outcome: Mass balance and pharmacokinetics
• Secondary Outcome: Pharmacokinetics of parent drug and its metabolite, safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Male

Include 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)

Exclude 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)

Related Information

• Primary Sponsor: Inoguchi Akihiro