ADME Study of [14C]-orvepitant in Healthy Male Volunteers (QSC203304)
Research type
Research Study
Full title
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]-orvepitant in Healthy Male Subjects After Oral Dosing
IRAS ID
278021
Contact name
Elizabeth Ballantyne
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd.
Eudract number
2020-000499-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 30 days
Research summary
The Sponsor is developing the test medicine, orvepitant, for the potential treatment of refractory or unexplained chronic cough (RUCC). RUCC is a cough lasting for at least eight weeks, with no apparent underlying cause, where normal treatment methods do not lead to an improvement. The test medicine aims to inhibit over stimulation of the coughing reflex by blocking the mechanism thought to be responsible.
The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body. The study will try to assess how much radioactivity can be recovered from the blood, urine and faeces (mass balance recovery) after a single oral dose of [14C]-orvepitant. It will also look to identify the breakdown products (metabolites) of the parent drug. In addition it will determine the rate and route of elimination of [14C]-orvepitant, along with the level of test medicine in the blood. The safety and tolerability of the test medicine will be assessed.
The study will consist of one study period involving up to six healthy male volunteers. Up to six volunteers will receive a single oral dose of 30 mg of the radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours (Day 8). If the required level of radioactivity has not been recovered by this point, the residency period may be extended up to Day 10. For individual volunteers an additional blood sample may be collected at a return visit on Day 14 for measurement of metabolites.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0619
Date of REC Opinion
22 Apr 2020
REC opinion
Favourable Opinion