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

Quantum Genomics

Status and phase: Completed; Phase 1

Conditions: Healthy Males

Treatments: Drug: Firibastat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03714685

QSC118052 (Other Identifier)

QGC001-1QG3

2018-001909-89 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing and for each treatment period they will be admitted to the clinical unit on the evening prior to IMP administration (Day -1). On the morning of Day 1, subjects will receive IMP in the fasted state (or following a FDA standard high-fat breakfast, if applicable) and will remain on site until 48 h post-dose. Between the periods, an interim analysis and review of safety and PK data from dosed regimens will be performed in order to determine which Firibastat (QGC001) MR prototype tablet formulation and dose to administer in subsequent periods. A follow-up phone call will take place 7 to 10 days post-final dose to ensure the ongoing wellbeing of the subjects.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Firibastat prototype tablet formulations

Experimental group

Description:

Firibastat (QGC001) 500 mg modified release prototype tablet formulations or immediate release capsule formulation - 1 tablet or 1 capsule administered per period

Treatment:

Drug: Firibastat