New Formulation and Food Effect Study of BIIB074

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Trigeminal Neuralgia (TN), Other Neuropathic Pain

Intervention / Treatment
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* Drug: BIIB074 Treatment A
* Drug: BIIB074 Treatment B
* Drug: BIIB074 Treatment C
* Drug: BIIB074 Treatment D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Treatment sub groups A and B | Drug: BIIB074 Treatment A<br>* Lower dose RCF fasted<br>Drug: BIIB074 Treatment B<br>* Lower dose DCF fasted<br>|
| Experimental: Cohort 2<br>Treatment sub groups C and D | Drug: BIIB074 Treatment C<br>* Higher dose DCF fasted<br>Drug: BIIB074 Treatment D<br>* Higher dose DCF fed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax) |  | Day 1, 2, 3, 8, 9, 10 | 
| 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) |  | Day 1, 2, 3, 8, 9, 10 | 
| PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞) |  | Day 1, 2, 3, 8, 9, 10 | 
| PK of BIIB074 DCF as assessed by Cmax |  | Day 1, 2, 3, 8, 9, 10 | 
| PK of BIIB074 DCF as assessed by AUClast |  | Day 1, 2, 3, 8, 9, 10 | 
| PK of BIIB074 DCF as assessed by AUC∞ |  | Day 1, 2, 3, 8, 9, 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Up to Day 18 | 
| Number of participants with clinically significant laboratory assessment abnormalities |  | Up to Day 10 | 
| Number of participants with clinically significant vital sign abnormalities |  | Up to Day 10 | 
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities |  | Up to Day 10 | 
| Number of participants with clinically significant physical examinations abnormalities |  | Up to Day 10 |