Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
- Conditions
- Healthy VolunteerPharmacokinetics of ASP015K
- Interventions
- Drug: Placebo
- Registration Number
- NCT01225224
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
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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
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Written informed consent obtained from the subject personally
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Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study
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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
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Received or is scheduled to receive drug treatment within 7 days prior to the drug administration
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A history of drug allergies
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Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Single Japanese Group Placebo Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. Placebo Single Caucasian Group Placebo Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. Placebo Multiple Group Placebo Participants will receive placebo in three stages, each stage corresponding to a different dosage level. Placebo will be administered at 12-hour intervals after breakfast and dinner for seven days. ASP015K Single Caucasian Group peficitinib Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K Single Japanese Group peficitinib Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K Multiple Group peficitinib Participants will receive ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K will be administered at 12-hour intervals after breakfast and dinner for seven days.
- Primary Outcome Measures
Name Time Method Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests For 48 hours after administration
- Secondary Outcome Measures
Name Time Method Urinary unchanged drug concentration For 48 hours after administration Plasma unchanged drug concentration For 48 hours after administration Transcription factor phosphorylation level For 48 hours after administration