Mass Balance Study of [14C] TAS-205 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: TAS-205, [14C]TAS-205

• Registration Number: NCT04825431
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]TAS-205 following oral single doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-04-01
• Primary Completion: 2021-06-15
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Healthy adult male who provided written informed consent to participate in the study
2. Aged 20 years or older and younger than 40 years at the time of informed consent
3. Capable of oral intake.
4. Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0

Key Exclusion Criteria

1. Had current or previous hypersensitivity or allergy to drugs
2. Had current or previous drug abuse (including use of illicit drugs) or alcoholism
3. Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded)
4. Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
5. Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:

Systolic blood pressure: <90 mmHg or ≥140 mmHg, Diastolic blood pressure: <40 mmHg or ≥90 mmHg, Pulse rate: <40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS-205, [14C]TAS-205	TAS-205, [14C]TAS-205	-

Primary Outcome Measures

Name	Time	Method
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205	Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.	Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).	Day 1 to Day 8
Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.	Day 1 to Day 8

Trial Locations

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan