New Formulation and Food Effect Study of BIIB074

Biogen

Status and phase: Completed; Phase 1

Conditions: Trigeminal Neuralgia (TN); Other Neuropathic Pain

Treatments: Drug: BIIB074 Treatment A; Drug: BIIB074 Treatment D; Drug: BIIB074 Treatment B; Drug: BIIB074 Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02951221

802HV107

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Treatment sub groups A and B

Treatment:

Drug: BIIB074 Treatment A

Drug: BIIB074 Treatment B

Cohort 2

Experimental group

Description:

Treatment sub groups C and D

Treatment:

Drug: BIIB074 Treatment D

Drug: BIIB074 Treatment C