PK of Simeprevir, Odalasvir and AL-335 in healthy Japanese subjects
Research type
Research Study
Full title
A Phase 1, open-label, fixed sequence study to investigate the pharmacokinetic interaction between 2 direct acting antiviral agents odalasvir and AL-335 and between 3 direct acting antiviral agents simeprevir, odalasvir and AL-335 at steady state in healthy Japanese subjects.
IRAS ID
203738
Sponsor organisation
Janssen Research & Development
Eudract number
2016-000950-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
We are conducting this clinical study with three investigational drugs known as odalasvir (ODV), Simeprevir (SMV) and AL-335, which are either being developed (AL-335 and ODV) or are currently used (SMV) to treat Hepatitis C. This is a chronic condition of the liver caused by the Hepatitis C virus.\n\nCurrently, Hepatitis C is treated with a combination of different drugs that interfere with the virus’ ability to replicate (make copies of itself). A combination of three effective anti-viral drugs, each with a different mechanism of action, may increase treatment effectiveness. This may allow shorter overall treatment durations and may be useful in treating more difficult-to-cure patients. \n\nBoth ODV and AL-335 have already been trialled before in non-Japanese volunteers (healthy and patient). SMV is currently used to treat Hepatitis C patients worldwide, in combination with other anti-viral medications. A drug interaction study using these three drugs has already been conducted in non-Japanese healthy volunteers, with good safety and tolerability results. We are now conducting this study to investigate using ODV, AL-335 and SMV in combination in healthy Japanese volunteers. The data from this study will be used to see whether there is any difference in how these drugs are handled by the body and how safe the drugs are in Japanese people compared to non-Japanese people. This information can then be used to support treating Japanese Hepatitis C patients with these three drugs in the future. \n\nIn this study, 16 volunteers will receive multiple doses of AL-335, ODV and SMV in different combinations over 36 days. The dose of each drug remains constant over the treatment period, with the exception of a single higher loading dose of ODV. They will have nine outpatient visits over 14 days following the last day of dosing. The final follow-up is scheduled 35 days post-last dose.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0524
Date of REC Opinion
18 May 2016
REC opinion
Further Information Favourable Opinion