New Formulation and Food Effect Study of BIIB074

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

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.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia (TN); Other Neuropathic Pain
• Intervention / Treatment: Drug: BIIB074 Treatment A; Drug: BIIB074 Treatment B; Drug: BIIB074 Treatment C; Drug: BIIB074 Treatment D

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; Treatment sub groups A and B	Drug: BIIB074 Treatment A; Lower dose RCF fasted; Drug: BIIB074 Treatment B; Lower dose DCF fasted
EXPERIMENTAL: Cohort 2; Treatment sub groups C and D	Drug: BIIB074 Treatment C; Higher dose DCF fasted; Drug: BIIB074 Treatment D; Higher dose DCF fed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 802HV107