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

February 26, 2013 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum alefacept pharmacokinetic parameters
Time Frame: Days 1-8,15, 22, 29 and 43
Days 1-8,15, 22, 29 and 43

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets
Time Frame: Days 1-8, 15, 22, 29 and 43
Days 1-8, 15, 22, 29 and 43
Safety variables including anti-alefacept antibodies
Time Frame: Days 1-8, 15, 22, 29 and 43
Days 1-8, 15, 22, 29 and 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0485-CL-J101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe