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

May 31, 2012
June 12, 2014
June 2012
October 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01610310 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic 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 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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy
  • Multiple Sclerosis
  • 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 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.
    Interventions:
    • Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
    • Device: BIIB017 (peginterferon beta-1a) Autoinjector
  • 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.
    Interventions:
    • Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
    • Device: BIIB017 (peginterferon beta-1a) Autoinjector
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

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
Study Director: Medical Director Biogen Idec
Biogen Idec
June 2014

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