PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects

The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).

Study Overview

• Status: Completed
• Conditions: Healthy; Trigeminal Neuralgia
• Intervention / Treatment: Drug: BIIB074; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Japanese or Caucasian.
• Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
• Must have a body mass index between 18 and 30 kg/m2, inclusive.

Key Exclusion Criteria:

• Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
• Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; 48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio	Drug: BIIB074; Administered as specified in the treatment arm; Other Names: CNV1014802; Drug: Placebo; Matched Placebo
Experimental: Part 2; 16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day	Drug: BIIB074; Administered as specified in the treatment arm; Other Names: CNV1014802; Drug: Placebo; Matched Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)	15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)	15 minutes prior to dosing up to 96 hours post dose
Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by tmax	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC	15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant laboratory assessment abnormalities	Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant vital sign abnormalities	Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities	Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant physical examinations abnormalities	Up to 2 weeks post Part 2 of the Treatment Period

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 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: 802HV106; 2016-000874-39 (EudraCT Number)