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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825431
• Other study ID #: 10053070
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2021
• Est. completion date: May 27, 2022

Study information

• Verified date: August 2022
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 27, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• TAS-205, [14C]TAS-205
single oral administration under fasted conditions on day 1

Locations

Country	Name	City	State
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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