A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000034454
- Lead Sponsor
- Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1. Have a significant complication which may affect drug evaluation, such as digestive, liver, musculoskeletal, respiratory, brain, cardiovascular, blood, tumor, endocrine, immune, nervous, psychiatric, urogenital diseases 2. Subjects who have complications or history of kidney disease 3. Subjects who have complications or history of liver disease 4. Subjects who have a history of surgical operations or medical disorders judged by the investigator that may affect the absorption, distribution, metabolism, excretion of the drug 5. Subjects who used drugs or herbal medicine products within 2 weeks before the investigational drug administration or who may need such drugs 6. Subjects who ingested grapefruit, oranges or apples and juice or foods containing them within 72 hours before the investigational drug administration 7. Subjects who took alcohol exceeding 10 units per week 8. Subjects who habitually ingest coffee, tea, green tea, cola, other caffeinated beverages exceeding 6 cups per day 9. Smokers or subjects who smoked or used nicotine containing products within 6 months before the screening test 10. Subjects who collected 400 mL or more of blood within 12 weeks or collected 200 mL of blood within 4 weeks or donated blood component within 2 weeks before the study drug administration, or subjects who collected more than 1200 mL of blood per year 11. Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration 12. Have surgical operations for 4 weeks before screening tests 13. Subjects with a history of severe or multiple allergies, or with a history of hypersensitivity reaction to drugs 14. Have a history of drug or alcohol abuse 15. Subjects with significant electrocardiogram abnormalities, including QTcF> 450 msec in screening tests 16. Positive for immunological test 17. Women who are or may be pregnant, who are lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of single and repeated doses of ART-648/TAK-648
- Secondary Outcome Measures
Name Time Method - Pharmacokinetics of single and repeated doses of ART-648/TAK-648 - Pharmacodynamics of single dose of ART-648/TAK-648