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

May 31, 2012
November 1, 2012
June 2012
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01610310 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Peginterferon Beta-1a (BIIB017) Autoinjector PK Study in Healthy Volunteers
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy Volunteers
  • Multiple Sclerosis
  • 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: 1
    BIIB017 administered first by PFS then by autoinjector
    Interventions:
    • Device: BIIB017 Pre-filled syringe (PFS)
    • Device: BIIB017 Autoinjector
  • Experimental: 2
    BIIB017 administered first by autoinjector then by PFS
    Interventions:
    • Device: BIIB017 Pre-filled syringe (PFS)
    • Device: BIIB017 Autoinjector
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01610310
105HV103
No
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP