NCT04825431
Completed
Phase 1
A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- TAS-205, [14C]TAS-205
- Conditions
- Healthy Male Subjects
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.
Investigators
Eligibility Criteria
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:
Exclusion Criteria
- Not provided
Arms & Interventions
TAS-205, [14C]TAS-205
Intervention: TAS-205, [14C]TAS-205
Outcomes
Primary Outcomes
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
Time Frame: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.
Time Frame: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
Time Frame: Day 1 to Day 8
Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.
Time Frame: Day 1 to Day 8
Study Sites (1)
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