Clinical trial NCT02951221: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Trigeminal Neuralgia (TN)
Other Neuropathic Pain
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
timeFrame: Day 1, 2, 3, 8, 9, 10
measure: 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)
timeFrame: Day 1, 2, 3, 8, 9, 10
measure: PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
timeFrame: Day 1, 2, 3, 8, 9, 10
measure: PK of BIIB074 DCF as assessed by Cmax
timeFrame: Day 1, 2, 3, 8, 9, 10
measure: PK of BIIB074 DCF as assessed by AUClast
timeFrame: Day 1, 2, 3, 8, 9, 10
measure: PK of BIIB074 DCF as assessed by AUC∞
timeFrame: Day 1, 2, 3, 8, 9, 10
Secondary outcomes:
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 18
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to Day 10
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: Up to Day 10
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to Day 10
measure: Number of participants with clinically significant physical examinations abnormalities
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: