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

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthy, Trigeminal Neuralgia

Intervention / Treatment
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* Drug: BIIB074
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio | Drug: BIIB074<br>* Administered as specified in the treatment arm<br>* Other names: CNV1014802;Drug: Placebo<br>* Matched Placebo<br>|
| Experimental: Part 2<br>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<br>* Administered as specified in the treatment arm<br>* Other names: CNV1014802;Drug: Placebo<br>* Matched Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |