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drugset / Trial / NCT03714685

Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations

NCT03714685 ↗

Phase 1 Completed 12 enrolled Quantum Genomics SA Quotient Sciences · collab
SequentialOpen-labelBasic science

Summary

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).

Timeline

Start
2019-02-15
Primary completion
2019-05-15
Completion
2019-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Firibastat Small molecule 500 mg Oral

Indications

No indication recorded.