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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01225224
First received: October 19, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 19, 2010
October 19, 2010
November 2009
March 2010   (final data collection date for primary outcome measure)
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Plasma unchanged drug concentration [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
  • Urinary unchanged drug concentration [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
  • Transcription factor phosphorylation level [ Time Frame: For 48 hours after administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Healthy Volunteer
  • Pharmacokinetics of ASP015K
  • Drug: ASP015K
    oral
  • Drug: Placebo
    oral
  • Experimental: ASP015K Single Japanese Group
    Intervention: Drug: ASP015K
  • Experimental: ASP015K Single Caucasian Group
    Intervention: Drug: ASP015K
  • Placebo Comparator: Placebo Single Japanese Group
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo Single Caucasian Group
    Intervention: Drug: Placebo
  • Experimental: ASP015K Multiple Group
    Intervention: Drug: ASP015K
  • Placebo Comparator: Placebo Multiple Group
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01225224
015K-CL-HV03
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP