New Formulation and Food Effect Study of BIIB074

Trigeminal Neuralgia (TN) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951221
• Other study ID #: 802HV107
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2016
• Last updated: February 23, 2017
• Start date: December 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Other Neuropathic Pain
• Trigeminal Neuralgia
• Trigeminal Neuralgia (TN)

Intervention

Drug:
• BIIB074 Treatment A
Lower dose RCF fasted
• BIIB074 Treatment B
Lower dose DCF fasted
• BIIB074 Treatment C
Higher dose DCF fasted
• BIIB074 Treatment D
Higher dose DCF fed

Locations

Country	Name	City	State
United States	Research Site	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)		Day 1, 2, 3, 8, 9, 10
Primary	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
Primary	PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC8)		Day 1, 2, 3, 8, 9, 10
Primary	PK of BIIB074 DCF as assessed by Cmax		Day 1, 2, 3, 8, 9, 10
Primary	PK of BIIB074 DCF as assessed by AUClast		Day 1, 2, 3, 8, 9, 10
Primary	PK of BIIB074 DCF as assessed by AUC8		Day 1, 2, 3, 8, 9, 10
Secondary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Day 18
Secondary	Number of participants with clinically significant laboratory assessment abnormalities		Up to Day 10
Secondary	Number of participants with clinically significant vital sign abnormalities		Up to Day 10
Secondary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to Day 10
Secondary	Number of participants with clinically significant physical examinations abnormalities		Up to Day 10