Healthy Male Subjects
Conditions
Keywords
Mass balance
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.
Interventions
DRUG14C-FYU-981
14C-FYU-981, (Oral single dosing)
Sponsors
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 (MRT: Mean residence time) | 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 |
Countries
Japan
Outcome results
None listed