Status:
COMPLETED
Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics of ASP015K
Healthy Volunteer
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
Detailed Description
This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to ...
Eligibility Criteria
Inclusion
- Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results
- Weight
- Japanese: ≥ 50.0 kg to \< 80.0 kg
- Caucasians: ≥ 50.0 kg to \< 100.0 kg
- BMI
- Japanese: ≥ 17.6 kg/m2 to \< 26.4 kg/m2
- Caucasians: ≥ 18.0 kg/m2 to \< 30.0 kg/m2
- Written informed consent obtained from the subject personally
Exclusion
- Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study
- Collection of 400 mL of whole blood within 90 days prior to the study,
- 200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study
- Received or is scheduled to receive drug treatment within 7 days prior to the drug administration
- A history of drug allergies
- Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission
- Concurrent or previous liver disease, e.g., viral hepatitis or drug-induced hepatic injury
- Concurrent or previous heart disease, e.g., congestive heart failure, angina pectoris or arrhythmias requiring treatment
- Concurrent or previous kidney disease, e.g., acute renal failure,
- glomerulonephritis or interstitial nephritis (except for previous urinary
- calculus)
- Concurrent or previous cerebrovascular disease, e.g., cerebral infarction
- Concurrent or previous malignancy
- Concurrent or previous active or recurrent infection, e.g., hepatitis B,
- hepatitis C or syphilis
Key Trial Info
Start Date :
November 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01225224
Start Date
November 18 2009
End Date
March 10 2010
Last Update
October 16 2024
Active Locations (1)
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1
Kyushu, Japan