Phase 1 Pharmacokinetic Study in Healthy Male Volunteers (QSC118052)
Research type
Research Study
Full title
A Study in Healthy Subjects Designed to Evaluate the Pharmacokinetic Profile of Firibastat (QGC001) and Active Metabolites, EC33 and QGC515, Following Administration of Firibastat (QGC001) Prototype Tablet Formulations
IRAS ID
246867
Contact name
Dr Bruno Besse
Contact email
Sponsor organisation
Quantum Genomics
Eudract number
2018-001909-89
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
The Sponsor is developing the test medicine, Firibastat (QGC001) to treat hypertension, which is high blood pressure. High blood pressure puts extra strain on the blood vessels, heart and other organs such as brain, kidneys and eyes. If left untreated, it can increase the risk of serious and potentially life-threatening conditions such as heart attacks and strokes.
Quantum Genomics want to develop a modified release version of the test medicine meaning that it will only have to be taken once per day. This study will test new recipes (formulations) of the test medicine. The study will try to identify the level of the study drug present in the blood after the volunteers have taken one dose of the new recipes of the test medicine. The study will also assess the safety and tolerability of the test medicine.
The study will consist of 5 periods involving up to 12 healthy male volunteers. The volunteers will receive one dose of the test medicine as tablets or a reference capsule at each period. The volunteers will attend the clinical unit on 5 occasions for each period, where the volunteers will be dosed on Day 1 and be discharged on Day 3. There will be a break of at least 7 days between each period. The volunteers will have a follow up phone call 7 to 10 days after their last dose to check the ongoing wellbeing of the volunteers.
REC name
HSC REC A
REC reference
18/NI/0157
Date of REC Opinion
8 Oct 2018
REC opinion
Further Information Favourable Opinion