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

A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04825431

Enrollment

Registered

2021-04-01

Start date

2021-03-22

Completion date

2022-05-27

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

Brief summary

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

Interventions

DRUGTAS-205, [14C]TAS-205

single oral administration under fasted conditions on day 1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

Key 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

Design outcomes

Primary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026