Characterise and compare PK for different oral formulations of RV521
Research type
Research Study
Full title
An open-label, single dose, four sequence study in healthy adult volunteers to evaluate the pharmacokinetics, safety and tolerability of RV521 administered as the drug in capsule and dry powder blend formulations in the fed state and the dry powder blend formulation dispersed in water in the fed and fasted states
IRAS ID
262767
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
ReViral Ltd
Eudract number
2019-000976-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
Richmond Pharmacology are conducting a clinical study with an experimental (not yet marketed) drug known as RV521. 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 202 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 related to RV521 prevented volunteers from completing the studies.
The main aims of this study are to investigate the way the body handles RV521 when it is given as two different formulations and when the dry powder blend formulation is dispersed in water and administered after food or whilst fasting.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0152
Date of REC Opinion
17 Apr 2019
REC opinion
Favourable Opinion