Mass Balance Study of FYU-981
Phase 2
Completed
- Conditions
- Healthy Male Subjects
- Interventions
- Drug: 14C-FYU-981
- Registration Number
- NCT02901366
- Lead Sponsor
- Fuji Yakuhin Co., Ltd.
- Brief Summary
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Japanese healthy adult subjects
- Body mass index: >=18.5 and <25.0
Exclusion Criteria
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
- Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
- Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
- Occupationally exposed worker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14C-FYU-981 14C-FYU-981 14C-FYU-981, (Oral single dosing)
- Primary Outcome Measures
Name Time Method Pharmacokinetics (MRT: Mean residence time) 168 hours Pharmacokinetics (Cmax: Maximum plasma concentration) 168 hours Pharmacokinetics (AUC: Area under the plasma concentration-time curve) 168 hours Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) 168 hours Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) 168 hours Pharmacokinetics (kel: Elimination rate constant) 168 hours Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed 168 hours Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) 168 hours Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air) 168 hours or 72 hours (Ae(air)) Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air) 168 hours or 72 hours (Ae(air)) Pharmacokinetics (Ae(total): Total amount of radioactivity excreted) 168 hours Pharmacokinetics (fe(total): Total fraction of radioactivity excreted) 168 hours Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air) 168 hours Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air) 168 hours Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces) 168 hours
- Secondary Outcome Measures
Name Time Method