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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225224
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Pharmacokinetics of ASP015K Drug: ASP015K Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: ASP015K Single Japanese Group Drug: ASP015K
Experimental: ASP015K Single Caucasian Group Drug: ASP015K
Placebo Comparator: Placebo Single Japanese Group Drug: Placebo
Placebo Comparator: Placebo Single Caucasian Group Drug: Placebo
Experimental: ASP015K Multiple Group Drug: ASP015K
Placebo Comparator: Placebo Multiple Group Drug: Placebo

Primary Outcome Measures :
  1. Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests [ Time Frame: For 48 hours after administration ]

Secondary Outcome Measures :
  1. Plasma unchanged drug concentration [ Time Frame: For 48 hours after administration ]
  2. Urinary unchanged drug concentration [ Time Frame: For 48 hours after administration ]
  3. Transcription factor phosphorylation level [ Time Frame: For 48 hours after administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225224

Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01225224     History of Changes
Other Study ID Numbers: 015K-CL-HV03
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2010

Keywords provided by Astellas Pharma Inc:
Ethnic difference