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

Study Overview
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Brief Summary
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A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.

Detailed Description
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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.

Official Title
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Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

Conditions
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Pharmacokinetics of ASP015K, Healthy Volunteer

Intervention / Treatment
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* Drug: peficitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP015K Single Japanese Group<br>Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Experimental: ASP015K Single Caucasian Group<br>Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level. | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Placebo Comparator: Placebo Single Japanese Group<br>Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. | Drug: Placebo<br>* oral<br>|
| Placebo Comparator: Placebo Single Caucasian Group<br>Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level. | Drug: Placebo<br>* oral<br>|
| Experimental: ASP015K Multiple Group<br>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. | Drug: peficitinib<br>* oral<br>* Other names: ASP015K;|
| Placebo Comparator: Placebo Multiple Group<br>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. | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests |  | For 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP015K, Ethnic difference