CLINICAL TRIALS PROFILE FOR FIRIBASTAT
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Clinical Trials for Firibastat
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03714685 ↗ | Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations | Completed | Quotient Sciences | Phase 1 | This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference Firibastat (QGC001) immediate release (IR) capsule formulation in healthy male subjects. It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal product (IMP). |
| NCT03714685 ↗ | Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations | Completed | Quantum Genomics SA | Phase 1 | This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference Firibastat (QGC001) immediate release (IR) capsule formulation in healthy male subjects. It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal product (IMP). |
| NCT03715998 ↗ | Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction | Recruiting | Quantum Genomics SA | Phase 2 | This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI. |
| NCT04277884 ↗ | Firibastat in Treatment-resistant Hypertension | Recruiting | Quantum Genomics SA | Phase 3 | This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments. |
| NCT04792333 ↗ | Pharmacokinetics in End Stage Renal Disease Patients | Completed | Eurofins Optimed | Phase 1 | The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis. |
| NCT04792333 ↗ | Pharmacokinetics in End Stage Renal Disease Patients | Completed | Quantum Genomics SA | Phase 1 | The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis. |
| NCT04857840 ↗ | Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH) | Recruiting | PRA Health Sciences | Phase 3 | This is a double-blind, placebo-controlled and open-label, multicenter efficacy and long-term safety study of firibastat (QGC001) 1000 mg (2×500 mg tablets) administered po, QD, for up to 48 weeks in patients with difficult-to-treat/treatment-resistant HTN. Subjects will continue to take their chronic antihypertensive therapies (at least 2 classes of antihypertensive therapies) at the MTDs during the Run in Period and for the duration of the study. For treatment-resistant subjects, one of the antihypertensive therapies must be a diuretic; for difficult-to-treat subjects, the antihypertensive therapies do not have to include a diuretic. Subjects will complete subject medication diaries during the Run-in Period. If systolic automated office BP (AOBP) is ≥180 mmHg or diastolic BP (DBP) ≥110 mmHg at any visit during the study (and repeated and confirmed within 30 min), the subject will be withdrawn from the study and will receive appropriate treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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