Safety, Tolerability & PK of odalasvir and AL-335 in healthy Japanese
Research type
Research Study
Full title
A Phase 1, double-blind, placebo-controlled, randomized, single ascending dose study to investigate the pharmacokinetics, safety and tolerability of odalasvir and AL-335 in healthy Japanese subjects.
IRAS ID
202384
Sponsor organisation
Janssen Research & Development
Eudract number
2015-005639-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
We are conducting a clinical study of the drugs odalasvir (ODV) and AL-335 in Japanese volunteers. These are experimental drugs being developed by Janssen Research & Development as a treatment for Hepatitis C, a serious liver disease 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). Combining two or more 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. ODV and AL-335 work differently to inhibit virus replication. \n\nBoth ODV and AL-335 have already been trialled before in both healthy and patient volunteers. We are conducting this study to investigate using both drugs in Japanese people to bridge between information gathered between non-Japanese and Japanese subjects. The safety and pharmacokinetic information gathered in this study will be used support giving these drugs to Japanese Hepatitis C patients. \n\nIn this study, volunteers will be allocated to one of two panels, which can run in parallel. Both panels have a screening period of 21 days. Panel 1 involves 30 Japanese volunteers, assigned to one of three escalating dose groups, receiving one single dose of ODV (or placebo). The treatment period is 14 days and follow-up occurs 35 days post-dose. In Panel 2, ten healthy Japanese subjects will receive 3 single oral doses of AL-335 (or placebo) in three treatment periods. The dose is increased in each period. The three treatment periods last 7 days each, and follow-up is 35 days after the last dose. \n\nThey are combined in one protocol to gather the data as efficiently as possible, and because these drugs are planned to be given together in clinical practice.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0584
Date of REC Opinion
24 May 2016
REC opinion
Further Information Favourable Opinion