Status:
COMPLETED
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Healthy Male Subjects
Eligibility:
MALE
20-39 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]TAS-205 following oral single doses.
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Healthy adult male who provided written informed consent to participate in the study
- Aged 20 years or older and younger than 40 years at the time of informed consent
- Capable of oral intake.
- Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
- Key Exclusion Criteria
- Had current or previous hypersensitivity or allergy to drugs
- Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- 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)
- Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04825431
Start Date
March 22 2021
End Date
May 27 2022
Last Update
August 8 2022
Active Locations (1)
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1
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan