Mass Balance Study of FYU-981

Fuji Yakuhin Co., Ltd.6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Male Subjects

Interventions

14C-FYU-981DRUG

14C-FYU-981, (Oral single dosing)

Eligibility

Sex: MALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Pharmacokinetics (Cmax: Maximum plasma concentration)

Time frame: 168 hours

Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

Time frame: 168 hours

Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

Time frame: 168 hours

Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

Time frame: 168 hours

Pharmacokinetics (kel: Elimination rate constant)

Time frame: 168 hours

Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed

Time frame: 168 hours

Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)

Time frame: 168 hours

Pharmacokinetics (MRT: Mean residence time)

Time frame: 168 hours

Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)

Time frame: 168 hours or 72 hours (Ae(air))

Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)

Time frame: 168 hours or 72 hours (Ae(air))

Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)

Time frame: 168 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.