Healthy Volunteer, Pharmacokinetics of ASP015K
Conditions
Keywords
ASP015K, Ethnic difference
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 evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.
Interventions
DRUGpeficitinib
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests | For 48 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Plasma unchanged drug concentration | For 48 hours after administration |
| Urinary unchanged drug concentration | For 48 hours after administration |
| Transcription factor phosphorylation level | For 48 hours after administration |
Countries
Japan
Outcome results
None listed