A five-part drug-drug interaction study of REN001 in healthy volunteers
Research type
Research Study
Full title
A Five-part, Phase 1, Open-label, Drug-drug Interaction Study Examining the Effect of Gemfibrozil, Fluconazole and Carbamazepine on the Safety, Tolerability and Pharmacokinetics of REN001, and the effect of REN001 on the Safety, Tolerability and Pharmacokinetics of Fexofenadine and Rosuvastatin in Healthy Subjects.
IRAS ID
1006047
Contact name
Gabrielle Brill
Contact email
Sponsor organisation
Reneo Pharma Ltd
Eudract number
2022-002224-13
ISRCTN Number
ISRCTN12840543
Research summary
The purpose of this study is to evaluate the study drug REN001. The study will enrol up to 82 healthy participants across 5 study parts (with Part E (carbamazepine) being considered as an optional study part). The overall objectives of the study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and potential for effects known as drug-drug interactions when the study drug is evaluated in different conditions i.e., different dose strengths and when administered alone and in combination with five different types of drugs. \n\nThe study will also evaluate the levels of two metabolite products of REN001 in the blood. Metabolites are by-products which are produced when a drug is broken down in the body. This study is classed as a drug-drug interaction study. This means that participants will be given a drug which has known effects and a known method of breakdown (metabolism) in the body (either gemfibrozil, fluconazole, fexofenadine, rosuvastatin or carbamazepine) and also given the study drug (REN001) to determine if there are any effects or interactions between the drugs in the body and whether administration of different types of drugs affects the safety, tolerability and concentration of REN001 in the blood, thereby affecting the desired effect of REN001 in the body. \n\nBlood samples will be taken at set time points throughout the study in order to measure the concentration of REN001 and other study drugs in the blood. The results from each of the study parts will be evaluated to determine if there are any significant differences in the safety profile of REN001, the concentration of REN001 in the blood and to determine whether there are any differences between different dose strengths of REN001 or any differences observed as a result of taking the drug in combination with five different types of drugs (drug-drug interaction).
REC name
Wales REC 1
REC reference
22/WA/0226
Date of REC Opinion
30 Aug 2022
REC opinion
Further Information Favourable Opinion