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

NCT04825431 | Completed Phase 1

• 1 other identifier: 10053070
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (4)

• Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205

  Day 1 to Day 8

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

  Day 1 to Day 8

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

  Day 1 to Day 8

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

  Day 1 to Day 8

Study Arms (1)

TAS-205, [14C]TAS-205

EXPERIMENTAL

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

Interventions

TAS-205, [14C]TAS-205 DRUG

single oral administration under fasted conditions on day 1

TAS-205, [14C]TAS-205

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

Related Publications (1)

• Hanada R, Takenaka T. Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor. Clin Pharmacol Drug Dev. 2025 Mar;14(3):200-208. doi: 10.1002/cpdd.1504. Epub 2025 Jan 22.

  PMID: 39840517 DERIVED

MeSH Terms

Interventions

TAS-205

Study Officials

• Taiho Pharmaceutical Co., Ltd.

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: June 15, 2021
• Study Completion: May 27, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)