Healthy Male Subjects Clinical Trial
Official title:
Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects
Verified date | August 2018 |
Source | Fuji Yakuhin Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | July 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fuji Yakuhin Co., Ltd. | Mochida Pharmaceutical Company, Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (Cmax: Maximum plasma concentration) | 168 hours | ||
Primary | Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 168 hours | ||
Primary | Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 168 hours | ||
Primary | Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 168 hours | ||
Primary | Pharmacokinetics (kel: Elimination rate constant) | 168 hours | ||
Primary | Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed | 168 hours | ||
Primary | Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 168 hours | ||
Primary | Pharmacokinetics (MRT: Mean residence time) | 168 hours | ||
Primary | Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air) | 168 hours or 72 hours (Ae(air)) | ||
Primary | Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air) | 168 hours or 72 hours (Ae(air)) | ||
Primary | Pharmacokinetics (Ae(total): Total amount of radioactivity excreted) | 168 hours | ||
Primary | Pharmacokinetics (fe(total): Total fraction of radioactivity excreted) | 168 hours | ||
Primary | Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air) | 168 hours | ||
Primary | Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air) | 168 hours | ||
Primary | Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces) | 168 hours |
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