Clinical trial NCT03714685: Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations
Official title: A Study in Healthy Subjects Designed to Evaluate the Pharmacokinetic Profile of Firibastat (QGC001) and Active Metabolites Following Administration of Firibastat (QGC001) Prototype Tablet Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Males
Lead sponsor: Quantum Genomics SA
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2018-10-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Maximum Plasma Concentration.
timeFrame: 3 months
measure: Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the time at which the Cmax is observed.
timeFrame: 3 months
measure: Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Areas Under the Curve.
timeFrame: 3 months
Secondary outcomes:
measure: Relative bioavailability of Firibastat (QGC001) modified release prototype tablet formulations compared to the immediate release capsule formulation
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing safety haematology and chemistry laboratory tests aggregated as number of patients outside normal ranges.
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing chemistry laboratory tests aggregated as number of patients outside normal ranges.
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing urinalysis aggregated as number of patients outside normal ranges.
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing AEs
timeFrame: 3 months
measure: Safety and tolerability of single doses of Firibastat (QGC001) by assessing Twelve-lead ECGs
timeFrame: 3 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
References: