802HV104 DDI Itraconazole effect on the PK of BIIB074
Research type
Research Study
Full title
An Open-Label, Fixed-Sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
IRAS ID
195930
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Covance - on behalf of Biogen
Eudract number
2015-005096-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 16 days
Research summary
BIIB074 is an investigational medicinal product which is being developed to treat neuropathic pain. BIIB074 works by blocking sodium channels responsible for conducting pain sensation. There are already drugs working in a similar method. BIIB074 is expected to have better tolerability and higher therapeutic index (i.e.: the dose causing toxicity of the drug in the body is far higher than the treatment dose).\nOne of the enzymes (enzymes help in metabolism) responsible for the breakdown (metabolism) of BIIB074 is CYP3A4 Therefore, other drugs which block CYP3A4 (e.g., itraconazole) have the potential to raise BIIB074 blood concentrations. This study is conducted to evaluate the change in blood concentration of BIIB074 when administered along with a strong CYP3A4 inhibitor itraconazole. Itraconazole is a strong CYP3A inhibitor and is commonly used in this type of drug-drug interaction studies.\nAfter checking in on day-1, the next day (Day 1) subjects will receive a single oral dose of BIIB074 150 mg and will reside at the clinic until Day 3.\nSubjects will return to the clinic on Day 7, and on Day 8 subjects will be administered itraconazole 200 mg twice. Subjects will be discharged after the second dose of itraconazole. Participants will self-administer itraconazole once daily (QD) on Days 9 and 10 and will return to the clinic on Day 10. On the morning of Day 11 subjects will be administered itraconazole 200 mg and BIIB074 150 mg. Subjects will continue to receive QD dosing of itraconazole through Day 15. Subjects will return to the clinic 7 to 10 days after the last administration of itraconazole for a safety Follow-up Visit. \n\nBIIB074 has been administered up to a dose of 825 mg in single dose studies. Overall, BIIB074 was generally well tolerated in previous studies. Doses of itraconazole 200 mg have been demonstrated to inhibit CYP3A4. \n
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0001
Date of REC Opinion
1 Feb 2016
REC opinion
Further Information Favourable Opinion