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Completed

NCT Number: NCT04825431

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

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

Completed

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Key information

Conditions

Healthy Male Subjects

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAS-205, [14C]TAS-205

Drug

single oral administration under fasted conditions on day 1

Primary outcomes

  1. 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

  2. Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.

    Time frame: Day 1 to Day 8

  3. Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).

    Time frame: Day 1 to Day 8

  4. Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.

    Time frame: Day 1 to Day 8

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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