Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
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 evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
Inclusion Criteria:
Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results
Weight
BMI
Written informed consent obtained from the subject personally
Exclusion Criteria:
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)
hepatitis C or syphilis
Kyushu, Japan