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

• Status: Completed
• Trial end date: 2019-06-07
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Quantum Genomics SA
• Collaborator: Quotient Sciences
• Treatments: Firibastat

Criteria

Inclusion Criteria:

• Body mass index of 18.0 to 32.0 kg/m2

• Must adhere to the contraception requirements

Exclusion Criteria:

• Subjects who have received any IMP in a clinical research study within the previous 3 months

• Subjects with pregnant partners

• History of any drug or alcohol abuse in the past 2 years

• Clinically significant abnormal biochemistry, haematology or urinalysis

• Subjects with BP <90/50 mmHg at screening