Other Neuropathic Pain, Trigeminal Neuralgia (TN)
Conditions
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.
Interventions
DRUGBIIB074 Treatment A
Lower dose RCF fasted
DRUGBIIB074 Treatment B
Lower dose DCF fasted
DRUGBIIB074 Treatment C
Higher dose DCF fasted
DRUGBIIB074 Treatment D
Higher dose DCF fed
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK of BIIB074 DCF as assessed by AUC∞ | Day 1, 2, 3, 8, 9, 10 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 18 |
Countries
United States
Outcome results
None listed