Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01610310
First received: May 31, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.


Condition Intervention Phase
Healthy
Multiple Sclerosis
Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
Device: BIIB017 (peginterferon beta-1a) Autoinjector
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞) [ Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Serum Concentration (Cmax) of peginterferon beta-1a [ Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 50 ] [ Designated as safety issue: Yes ]
  • Changes in clinical laboratory assessments [ Time Frame: Day 1 up to Day 50 ] [ Designated as safety issue: Yes ]
  • Vital sign changes [ Time Frame: Day 1 up to Day 50) ] [ Designated as safety issue: Yes ]
  • Physical exam changes [ Time Frame: Day 1 up to Day 50 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram changes [ Time Frame: Day 1 up to Day 50 ] [ Designated as safety issue: Yes ]
  • Clinician injection site assessment [ Time Frame: Days 1+2, 22+23 ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peginterferon beta-1a PFS/autoinjector
A single dose of peginterferon beta-1a 125 mcg administered by prefilled syringe (PFS) on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by autoinjector on Day 22.
Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Other Name: BIIB017
Device: BIIB017 (peginterferon beta-1a) Autoinjector
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other Name: BIIB017
Experimental: peginterferon beta-1a autoinjector / PFS
A single dose of peginterferon beta-1a 125 mcg administered by autoinjector on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by prefilled syringe (PFS) on Day 22.
Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Other Name: BIIB017
Device: BIIB017 (peginterferon beta-1a) Autoinjector
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other Name: BIIB017

Detailed Description:

This is a randomized, open-label, 2-sequence, 2-period crossover study that will be conducted at a single site in the United States to characterize the PK profile, safety and tolerability of peginterferon beta-1a delivered by autoinjector or PFS. Participants will be randomized in a 1:1 ratio to receive a single dose of peginterferon beta-1a at Day 1 delivered by either autoinjector or PFS, followed by a single dose of peginterferon beta 1a delivered by the other device at Day 22. The total duration of study participation is up to 3 months for each participant. Participants will complete a follow-up visit at Day 50 after the end of treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

1. Must have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive, and a minimum body weight of 50.0 kg

Key Exclusion Criteria:

  1. History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
  2. Female subjects who are pregnant or breastfeeding
  3. Any previous treatment with prescription or investigational pegylated drugs.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

  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: NCT01610310

Locations
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01610310     History of Changes
Other Study ID Numbers: 105HV103
Study First Received: May 31, 2012
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
SC
PEG
Inteferon
PK
Subcutaneous
PEGylated
Autoinjector
Injectable
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014