Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

NCT ID: NCT02269930

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2014-12-31

Brief Summary

The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29

Group Type: EXPERIMENTAL

peginterferon beta-1a

Intervention Type: DRUG

Administered as subcutaneous injection

Rebif

Intervention Type: DRUG

Administered as subcutaneous injection

Group 2

Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41

Group Type: EXPERIMENTAL

peginterferon beta-1a

Intervention Type: DRUG

Administered as subcutaneous injection

Rebif

Intervention Type: DRUG

Administered as subcutaneous injection

Interventions

peginterferon beta-1a

Administered as subcutaneous injection

Intervention Type: DRUG

Rebif

Administered as subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

BIIB017; Plegridy

Eligibility Criteria

Inclusion Criteria

• Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1

Exclusion Criteria

• History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb])
• History of premalignant and malignant disease including solid tumors and hematologic malignancies
• Known allergy to any interferon or any component of BIIB017
• Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Evansville, Indiana, United States

Countries

United States

References

Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.

Reference Type: DERIVED

PMID: 27060836 (View on PubMed)

Other Identifiers

105HV105

Identifier Type: -

Identifier Source: org_study_id