New Formulation and Food Effect Study of BIIB074

NCT02951221 | Completed Phase 1

• 1 other identifier: 802HV107
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia (TN); Other Neuropathic Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Treatment sub groups A and B

Drug: BIIB074 Treatment A; Drug: BIIB074 Treatment B

Cohort 2

EXPERIMENTAL

Treatment sub groups C and D

Drug: BIIB074 Treatment C; Drug: BIIB074 Treatment D

Interventions

BIIB074 Treatment A DRUG

Lower dose RCF fasted

Cohort 1

BIIB074 Treatment B DRUG

Lower dose DCF fasted

Cohort 1

BIIB074 Treatment C DRUG

Higher dose DCF fasted

Cohort 2

BIIB074 Treatment D DRUG

Higher dose DCF fed

Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

US (1)