New Formulation and Food Effect Study of BIIB074
Phase 1
Completed
- Conditions
- Trigeminal Neuralgia (TN)Other Neuropathic Pain
- Interventions
- Drug: BIIB074 Treatment CDrug: BIIB074 Treatment ADrug: BIIB074 Treatment B
- Registration Number
- NCT02951221
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 BIIB074 Treatment B Treatment sub groups A and B Cohort 2 BIIB074 Treatment C Treatment sub groups C and D Cohort 2 BIIB074 Treatment D Treatment sub groups C and D Cohort 1 BIIB074 Treatment A Treatment sub groups A and B
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Daytona Beach, Florida, United States