A PK Study of the Effect of Itraconazole Exposure to Orvepitant in HV
Research type
Research Study
Full title
A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Male Participants to Determine the Effect of an Inhibitor of Cytochrome P450 3A and P glycoprotein on Exposure to Orvepitant.
IRAS ID
243855
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
NeRRe Therapeutics Limited
Eudract number
2018-000320-34
Duration of Study in the UK
0 years, 2 months, 9 days
Research summary
This is a single-site, open-label, single-sequence crossover study in healthy male participants to look for an interaction between the study drug, orvepitant, and another drug called Itraconazole. The study will include a screening visit, two treatment periods and a safety follow-up visit. Participants will be resident at the clinical unit for 5 days/4 nights during Part 1 of the study (first treatment period) and 8 days/7 nights during Part 2 of the study (second treatment period).
This is not the first time orvepitant or Itraconazole is administered in humans. Orvepitant works in the brain and is being developed as therapy for chronic refractory cough (persistent unmanageable coughing). Orvepitant has been administered in more than 650 individuals in 10 previous clinical studies. Based on results from tests in laboratory animals and these clinical studies, the doses of orvepitant chosen for this study are thought to be safe. Itraconazole is an approved and commonly prescribed medication for the management of fungal infections. Based on scientific knowledge of how these two drugs are broken down by the body, there is the potential that when given together, the way orvepitant works in the body may be affected.
The main purpose of the study is to look for an interaction between orvepitant and Itraconazole. The study will investigate how orvepitant is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) when given with food to healthy male participants, with and without Itraconazole. In addition, the study will investigate the breakdown products (metabolites) of orvepitant. Genetic research is not evaluated in this study.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0653
Date of REC Opinion
10 May 2018
REC opinion
Further Information Favourable Opinion