Clinical trial NCT02831517: PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
Official title: A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Trigeminal Neuralgia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: 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)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
timeFrame: 15 minutes prior to dosing up to 96 hours post dose
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
measure: Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
timeFrame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Secondary outcomes:
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 2 weeks post Part 2 of the Treatment Period
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to 2 weeks post Part 2 of the Treatment Period
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: Up to 2 weeks post Part 2 of the Treatment Period
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to 2 weeks post Part 2 of the Treatment Period
measure: Number of participants with clinically significant physical examinations abnormalities
timeFrame: Up to 2 weeks post Part 2 of the Treatment Period
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: