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Peginterferon Beta-1a (BIIB017) Autoinjector PK 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: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Multiple Sclerosis
 Device: BIIB017 Pre-filled syringe (PFS)
Device: BIIB017 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:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • AUC of peginterferon beta-1a [ Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • Tmax of of peginterferon beta-1a [ Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22 ] [ Designated as safety issue: No ]
  • Terminal half-life 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 AEs and SAEs [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]
  • Changes in clinical laboratory assessments [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]
  • Vital sign changes [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]
  • Physical exam changes [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]
  • ECG changes [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]
  • Clinician injection site asssessment [ Time Frame: Through follow-up (Day 50) ] [ Designated as safety issue: Yes ]

Enrollment: 30
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: 1
BIIB017 administered first by PFS then by autoinjector
 Device: BIIB017 Pre-filled syringe (PFS)
125 mcg BIIB017 SC administered by PFS
Other Name: peginterferon beta-1a
Device: BIIB017 Autoinjector
125 mcg BIIB017 SC administered by autoinjector
Other Name: peginterferon beta-1a
Experimental: 2
BIIB017 administered first by autoinjector then by PFS
 Device: BIIB017 Pre-filled syringe (PFS)
125 mcg BIIB017 SC administered by PFS
Other Name: peginterferon beta-1a
Device: BIIB017 Autoinjector
125 mcg BIIB017 SC administered by autoinjector
Other Name: peginterferon beta-1a

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. Subjects 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 subject. Subjects 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

Inclusion Criteria:

  1. Must be healthy males or females between 18 to 45 years old, inclusive.
  2. Must have a body mass index (BMI) of 19 to 29 kg/m2, inclusive, and a minimum body weight of 50.0 kg

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.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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
  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: November 1, 2012
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
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013