Drug interactions with RV521 in healthy volunteers
Research type
Research Study
Full title
An adaptive, part open-label, part randomised Phase 1 clinical trial in healthy volunteers to study drug interactions with RV521 including those mediated by CYP3A4 and P-glycoprotein
IRAS ID
253083
Contact name
Ulrike Lorch
Contact email
Eudract number
2018-003256-21
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
Richmond Pharmacology are conducting a clinical study with an experimental (not yet marketed) drug known as RV521. This study will involve four cohorts (treatment groups) of healthy Caucasian volunteers. The study drug, RV521, is being developed by ReViral Ltd as a treatment for Respiratory Syncytial Virus (RSV) infection, which can cause severe chest infections in small children, adults with heart, lung and immune system conditions, elderly people and patients who have received transplants.
Currently, there are very few treatment options available for individuals with RSV infection and no vaccine exists to prevent infection. There is therefore an urgent need for a well-tolerated and effective treatment for RSV.
RV521 has been studied in the laboratory, in animal studies and previously in human studies, with approximately 120 volunteers, and was found to be well tolerated in single and multiple doses. The most frequent adverse reactions seen with RV521 in these studies were abdominal pain, diarrhoea, nausea and vomiting. There were low numbers of side effects, and these were largely mild and short-lasting. None of the side effects prevented volunteers from completing the studies.
The main aim of this study is to determine whether RV521 interacts with any other medication. We will investigate this using four licensed medicines that are known to have specific effects on enzymes and transporter proteins that influence the absorption of drugs. These medicines are called midazolam, itraconazole, verapamil and rifampicin. We intend to recruit a total of 104 volunteers to be included in this study in the following cohorts:
- Cohort 1a: Volunteers will be administered midazolam and RV521/placebo.
- Cohort 1b: This cohort is optional. The PIS/ICF has not been submitted. If required, details will be provided as a non-substantial amendment.
- Cohort 2: Volunteers will be administered itraconazole and RV521.
- Cohort 3: Volunteers will be administered verapamil and RV521.
- Cohort 4: Volunteers will be administered rifampicin and RV521.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0501
Date of REC Opinion
15 Oct 2018
REC opinion
Favourable Opinion