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

NCT02831517 | Completed Phase 1

• 2 other identifiers: 802HV1062016-000874-39
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy; Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (5)

• 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

Study Arms (2)

Part 1

EXPERIMENTAL

48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio

Drug: BIIB074; Drug: Placebo

Part 2

EXPERIMENTAL

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; Drug: Placebo

Interventions

BIIB074 DRUG

Administered as specified in the treatment arm

Also known as: CNV1014802

Part 1; Part 2

Placebo DRUG

Matched Placebo

Part 1; Part 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

vixotrigine

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

GB (1)