A phase 1 mass balance study of [14C]TAS-205 in healthy volunteers
- Conditions
- Duchenne Muscular Dystrophy
- Registration Number
- JPRN-jRCT2071210008
- Lead Sponsor
- asermoaddeli Ali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method