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

NCT00653822 | Completed Phase 1

• 1 other identifier: 0485-CL-J101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics of Alefacept

Keywords

Amevive; alefacept; pharmacokinetics; Japanese

Outcome Measures

Primary Outcomes (1)

• Serum alefacept pharmacokinetic parameters

  Days 1-8,15, 22, 29 and 43

Secondary Outcomes (2)

• Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets

  Days 1-8, 15, 22, 29 and 43

• Safety variables including anti-alefacept antibodies

  Days 1-8, 15, 22, 29 and 43

Study Arms (6)

1a

EXPERIMENTAL

IV

Drug: alefacept

1b

PLACEBO COMPARATOR

IV

Drug: placebo

2a

EXPERIMENTAL

Lower SC dose

Drug: alefacept

2b

PLACEBO COMPARATOR

SC to match lower dose

Drug: placebo

3a

EXPERIMENTAL

Higher SC dose

Drug: alefacept

3b

PLACEBO COMPARATOR

SC to match higher dose

Drug: placebo

Interventions

alefacept DRUG

IC and SC

Also known as: Amevive, ASP0485

1a; 2a; 3a

placebo DRUG

IV and SC

1b; 2b; 3b

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Use Central Contact

  Astellas Pharma US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 28, 2013

Record last verified: 2008-08

Locations

US (1)