Phase 1 study to evaulate the PK of QGC001 formulations (QSC202835)
Research type
Research Study
Full title
A Study in Healthy Subjects Designed to Evaluate the Pharmacokinetic Profile of Firibastat (QGC001) and Metabolites EC33 and QGC515 Following Multiple Dose Administration of QGC001 Immediate Release and Modified Release Formulations
IRAS ID
271848
Contact name
Dr Bruno Besse
Contact email
Sponsor organisation
Quantum Genomics
Eudract number
2019-003748-55
ISRCTN Number
ISRCTN24120533
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
The Sponsor, Quantum Genomics, is developing the test medicine, QGC001 (also known as firibastat), for the potential treatment of hypertension (high blood pressure). High blood pressure puts extra strain on the blood vessels, heart and other organs such as the brain, kidneys and eyes. If left untreated, it can increase the risk of serious and potentially life-threatening conditions such as heart failure, kidney insufficiency and strokes.
This study will try to identify the amount of test medicine present in the blood when given as different formulations (recipes) by mouth in fasted conditions. The safety and tolerability of the study drug will also be investigated.
The study will consist of one study period and is planned to enroll 3 groups of 10 healthy male and female volunteers where three test medicines will be dosed. In each group, the volunteers will be given one of three study treatments. In study treatment 1, volunteers will receive a 500 mg dose of the test medicine given as a capsule twice a day on Days 1-6 followed by a single dose on Day 7. In study treatment 2 volunteers will receive a single 1000 mg dose of the test medicine as a tablet on Days 1-7. In study treatment 3, volunteers will receive a single 1000 mg dose of the test medicine as a tablet (different recipe) on Days 1-7.
The volunteers will remain in the clinic for a total of 10 days (Day -1 – Day 9) to receive all doses of the test medicine over a 7 day period. Volunteers will have a follow-up call 7 to 10 days after their last dose to check on their continued wellbeing.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1799
Date of REC Opinion
2 Jan 2020
REC opinion
Further Information Favourable Opinion