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
  Purpose

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


Condition Intervention Phase
Healthy Volunteer
Pharmacokinetics of ASP015K
Drug: ASP015K
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP015K Single Japanese Group Drug: ASP015K
oral
Experimental: ASP015K Single Caucasian Group Drug: ASP015K
oral
Placebo Comparator: Placebo Single Japanese Group Drug: Placebo
oral
Placebo Comparator: Placebo Single Caucasian Group Drug: Placebo
oral
Experimental: ASP015K Multiple Group Drug: ASP015K
oral
Placebo Comparator: Placebo Multiple Group Drug: Placebo
oral

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

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225224

Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01225224     History of Changes
Other Study ID Numbers: 015K-CL-HV03
Study First Received: October 19, 2010
Last Updated: October 19, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP015K
Ethnic difference

ClinicalTrials.gov processed this record on September 22, 2014