A phase 1 mass balance study of [14C]TAS-205 in healthy volunteers

JRCT ID: jRCT2071210008

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Duchenne Muscular Dystrophy
• Date of first enrollment: 24/05/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Orally administer 80 mL of the liquid containing [14C]TAS-205 and TAS-205 on day 1.

Outcome(s)

Primary Outcome

- Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
- Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate into urine and feces.
- Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate in all excreta (urine and faeces).
- Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

(1) Healthy adult male subjects 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

Exclude 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 evaluations 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 bpm
Body temperature: 35.0 or >= 37.1

Related Information

• Primary Sponsor: Nasermoaddeli Ali
• Secondary ID(s): NCT04825431