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

Taiho Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: TAS-205, [14C]TAS-205

Study type: Interventional

Funder types: Industry

Identifiers

NCT04825431

10053070

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

TAS-205, [14C]TAS-205

Experimental group

Treatment:

Drug: TAS-205, [14C]TAS-205