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

  • 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

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.