Clinical trial NCT01225224: Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
Official title: Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of ASP015K
Healthy Volunteer
Keywords: ASP015K
Ethnic difference
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests
timeFrame: For 48 hours after administration
Secondary outcomes:
measure: Plasma unchanged drug concentration
timeFrame: For 48 hours after administration
measure: Urinary unchanged drug concentration
timeFrame: For 48 hours after administration
measure: Transcription factor phosphorylation level
timeFrame: For 48 hours after administration
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Shibata M, Hatta T, Saito M, Toyoshima J, Kaneko Y, Oda K, Nishimura T. Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects. Clin Drug Investig. 2020 May;40(5):469-484. doi: 10.1007/s40261-020-00910-w.