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).
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).
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.
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