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

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Primary Completion: 2017-01
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

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 (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