A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00653822
First received: April 2, 2008
Last updated: February 26, 2013
Last verified: August 2008
  Purpose

The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects


Condition Intervention Phase
Pharmacokinetics of Alefacept
Drug: alefacept
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: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Dose Study to Assess the Tolerability, Safety, and Pharmacokinetics of Alefacept in Caucasian and Japanese Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Serum alefacept pharmacokinetic parameters [ Time Frame: Days 1-8,15, 22, 29 and 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets [ Time Frame: Days 1-8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]
  • Safety variables including anti-alefacept antibodies [ Time Frame: Days 1-8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1a
IV
Drug: alefacept
IC and SC
Other Names:
  • Amevive
  • ASP0485
Placebo Comparator: 1b
IV
Drug: placebo
IV and SC
Experimental: 2a
Lower SC dose
Drug: alefacept
IC and SC
Other Names:
  • Amevive
  • ASP0485
Placebo Comparator: 2b
SC to match lower dose
Drug: placebo
IV and SC
Experimental: 3a
Higher SC dose
Drug: alefacept
IC and SC
Other Names:
  • Amevive
  • ASP0485
Placebo Comparator: 3b
SC to match higher dose
Drug: placebo
IV and SC

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
  • Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
  • Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator

Exclusion Criteria:

  • CD4+ lymphocyte count outside normal limits at Screening
  • Received vaccine within 60 days prior to study drug administration
  • History of drug or alcohol abuse within the 2 years prior to the study drug administration
  • Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
  • Treatment with any antibody or biologic product within 6 months prior to study drug administration
  • Treatment with any systemic steroid or steroid inhaler within 2 months prior to study drug administration
  • A smoking habit of greater than 10 cigarettes a day
  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: NCT00653822

Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00653822     History of Changes
Other Study ID Numbers: 0485-CL-J101
Study First Received: April 2, 2008
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Amevive
alefacept
pharmacokinetics
Japanese

Additional relevant MeSH terms:
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014