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NCT02901366 Clinical Trial

Mass Balance Study of FYU-981

Healthy Male Subjects Clinical Trial

Official title:
Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02901366
Other study ID # FYU-981-009
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2016
Est. completion date July 2018

Study information
Verified date August 2018
Source Fuji Yakuhin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 14C-FYU-981
14C-FYU-981, (Oral single dosing)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Fuji Yakuhin Co., Ltd. Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
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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