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

Primary Purpose

Healthy, Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

BIIB017 (peginterferon beta-1a) Autoinjector

About this trial

This is an interventional basic science trial for Healthy focused on measuring SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable, MS

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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:

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

peginterferon beta-1a PFS/autoinjector

peginterferon beta-1a autoinjector / PFS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of peginterferon beta-1a

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Changes in clinical laboratory assessments

Vital sign changes

Physical exam changes

Electrocardiogram changes

Clinician injection site assessment

Full Information

NCT ID

NCT01610310

First Posted

May 31, 2012

Last Updated

June 12, 2014

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01610310

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Multiple Sclerosis

Keywords

SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable, MS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

peginterferon beta-1a PFS/autoinjector

Arm Type

Experimental

Arm Description

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.

Arm Title

peginterferon beta-1a autoinjector / PFS

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

Other Intervention Name(s)

BIIB017

Intervention Description

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22

Intervention Type

Device

Intervention Name(s)

BIIB017 (peginterferon beta-1a) Autoinjector

Other Intervention Name(s)

BIIB017

Intervention Description

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Maximum Serum Concentration (Cmax) of peginterferon beta-1a

Time Frame

For 11 days (multiple timepoints) after each dose on Day 1 and 22

Title

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

Day 1 up to Day 50

Title

Changes in clinical laboratory assessments

Time Frame

Day 1 up to Day 50

Title

Vital sign changes

Time Frame

Day 1 up to Day 50)

Title

Physical exam changes

Time Frame

Day 1 up to Day 50

Title

Electrocardiogram changes

Time Frame

Day 1 up to Day 50

Title

Clinician injection site assessment

Time Frame

Days 1+2, 22+23

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

St. Paul

State/Province

Minnesota

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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