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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610310
• Other study ID #: 105HV103
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2012
• Last updated: June 12, 2014
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Multiple Sclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Research Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-8)		For 11 days (multiple timepoints) after each dose on Day 1 and 22	No
Secondary	Maximum Serum Concentration (Cmax) of peginterferon beta-1a		For 11 days (multiple timepoints) after each dose on Day 1 and 22	No
Secondary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 50	Yes
Secondary	Changes in clinical laboratory assessments		Day 1 up to Day 50	Yes
Secondary	Vital sign changes		Day 1 up to Day 50)	Yes
Secondary	Physical exam changes		Day 1 up to Day 50	Yes
Secondary	Electrocardiogram changes		Day 1 up to Day 50	Yes
Secondary	Clinician injection site assessment		Days 1+2, 22+23	Yes