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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831517
• Other study ID #: 802HV106
• Secondary ID: 2016-000874-39
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2016
• Last updated: March 7, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• 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:

• 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.

Related Conditions & MeSH terms

• Healthy
• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• BIIB074
Administered as specified in the treatment arm
• Placebo
Matched Placebo

Locations

Country	Name	City	State
United Kingdom	Research Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

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