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New Formulation and Food Effect Study of BIIB074

Primary Purpose

Trigeminal Neuralgia (TN), Other Neuropathic Pain

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BIIB074 Treatment A

BIIB074 Treatment B

BIIB074 Treatment C

BIIB074 Treatment D

About this trial

This is an interventional basic science trial for Trigeminal Neuralgia (TN)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Must have a body mass index between 18 and 30 kg/m2, inclusive.
Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.

Key Exclusion Criteria:

History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
Positive test result at Screening for hepatitis C virus antibody.
Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
Previous exposure to BIIB074.
Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study.
History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1.

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

Cohort 1

Cohort 2

Arm Description

Treatment sub groups A and B

Treatment sub groups C and D

Outcomes

Primary Outcome Measures

PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)

PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)

PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)

PK of BIIB074 DCF as assessed by Cmax

PK of BIIB074 DCF as assessed by AUClast

PK of BIIB074 DCF as assessed by AUC∞

Secondary Outcome Measures

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with clinically significant laboratory assessment abnormalities

Number of participants with clinically significant vital sign abnormalities

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Number of participants with clinically significant physical examinations abnormalities

Full Information

NCT ID

NCT02951221

First Posted

October 24, 2016

Last Updated

February 23, 2017

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02951221

Brief Title

New Formulation and Food Effect Study of BIIB074

Official Title

A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (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 primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.

6. Conditions and Keywords

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

Trigeminal Neuralgia (TN), Other Neuropathic Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Treatment sub groups A and B

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Treatment sub groups C and D

Intervention Type

Drug

Intervention Name(s)

BIIB074 Treatment A

Intervention Description

Lower dose RCF fasted

Intervention Type

Drug

Intervention Name(s)

BIIB074 Treatment B

Intervention Description

Lower dose DCF fasted

Intervention Type

Drug

Intervention Name(s)

BIIB074 Treatment C

Intervention Description

Higher dose DCF fasted

Intervention Type

Drug

Intervention Name(s)

BIIB074 Treatment D

Intervention Description

Higher dose DCF fed

Primary Outcome Measure Information:

Title

PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)

Time Frame

Day 1, 2, 3, 8, 9, 10

Title

PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)

Time Frame

Day 1, 2, 3, 8, 9, 10

Title

PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)

Time Frame

Day 1, 2, 3, 8, 9, 10

Title

PK of BIIB074 DCF as assessed by Cmax

Time Frame

Day 1, 2, 3, 8, 9, 10

Title

PK of BIIB074 DCF as assessed by AUClast

Time Frame

Day 1, 2, 3, 8, 9, 10

Title

PK of BIIB074 DCF as assessed by AUC∞

Time Frame

Day 1, 2, 3, 8, 9, 10

Secondary Outcome Measure Information:

Title

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

Up to Day 18

Title

Number of participants with clinically significant laboratory assessment abnormalities

Time Frame

Up to Day 10

Title

Number of participants with clinically significant vital sign abnormalities

Time Frame

Up to Day 10

Title

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Time Frame

Up to Day 10

Title

Number of participants with clinically significant physical examinations abnormalities

Time Frame

Up to Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Must have a body mass index between 18 and 30 kg/m2, inclusive. Must be in good health as determined by the Investigator, based on medical history and screening evaluations. Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe. Key Exclusion Criteria: History of, or positive test result at Screening for, human immunodeficiency virus (HIV). Positive test result at Screening for hepatitis C virus antibody. Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody). Previous exposure to BIIB074. Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation. History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study. History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1. 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

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

12. IPD Sharing Statement

Learn more about this trial

New Formulation and Food Effect Study of BIIB074

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