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

Tracking Information
First Received Date ^ICMJE	May 31, 2012
Last Updated Date	November 1, 2012
Start Date ^ICMJE	June 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 31, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01610310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 31, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Peginterferon Beta-1a (BIIB017) Autoinjector PK Study in Healthy Volunteers
Official Title ^ICMJE	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
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers Multiple Sclerosis
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	October 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must be healthy males or females between 18 to 45 years old, inclusive. 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: History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases Female subjects who are pregnant or breastfeeding Any previous treatment with prescription or investigational pegylated drugs. Other protocol-defined inclusion/exclusion criteria may apply.
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01610310
Other Study ID Numbers ^ICMJE	105HV103
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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