802HV106 PK and Safety Study of BIIB074 in Healthy Japanese subjects
Research type
Research Study
Full title
A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
IRAS ID
206392
Contact name
Firas Almazedi
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2016-000874-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 9 days
Research summary
BIIB074 is an investigational medicinal product which is being developed to treat trigeminal neuralgia (TN) and other types of neuropathic pain. BIIB074 works by blocking sodium channels responsible for conducting pain sensation. BIIB074 is expected to have better tolerability and higher therapeutic index (ie: the dose causing toxicity of the drug in the body is far higher than the treatment dose) than other similar drugs.\nBIIB074 has been generally well tolerated in 6 completed studies in healthy subjects.There have been no Phase 1 studies conducted in Japanese subjects as yet. This study will evaluate the pharmacokinetics (PK, drug concentration in blood after dosing), safety and tolerability of single and multiple doses in Japanese subjects. Caucasian subjects will be included in part 1 of the study to provide comparative PK data following single dose administration. \nThe study will be conducted in two parts:\nPart 1 is a blinded, placebo-controlled, single-ascending-dose study in Japanese and Caucasian subjects in 3 cohorts. Each cohort will consist of 8 Japanese subjects and 8 Caucasian subjects, with subjects of each race randomized to receive BIIB074 or placebo in a 6:2 ratio.\nPart 2 is a blinded, placebo-controlled, multiple-dose study in Japanese subjects in 2 cohorts. Each cohort will consist of 8 Japanese subjects, with each subject randomized to receive BIIB074 or placebo in a 6:2 ratio.\n \nIn Part 1 the total study duration will be 37 to 40 days and in Part 2 the total study duration will be 43 to 46 days.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0145
Date of REC Opinion
29 Jun 2016
REC opinion
Further Information Favourable Opinion