Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers

• Plasma unchanged drug concentration [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
• Urinary unchanged drug concentration [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
• Transcription factor phosphorylation level [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]

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.

• Healthy Volunteer
• Pharmacokinetics of ASP015K

• Drug: ASP015K
  oral
• Drug: Placebo
  oral

• Experimental: ASP015K Single Japanese Group
  Intervention: Drug: ASP015K
• Experimental: ASP015K Single Caucasian Group
  Intervention: Drug: ASP015K
• Placebo Comparator: Placebo Single Japanese Group
  Intervention: Drug: Placebo
• Placebo Comparator: Placebo Single Caucasian Group
  Intervention: Drug: Placebo
• Experimental: ASP015K Multiple Group
  Intervention: Drug: ASP015K
• Placebo Comparator: Placebo Multiple Group
  Intervention: Drug: Placebo

Inclusion Criteria:

• 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 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)
• 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