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

Healthy Males Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714685
• Other study ID #: QGC001-1QG3
• Secondary ID: QSC1180522018-00
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2019
• Est. completion date: June 7, 2019

Study information

• Verified date: June 2019
• Source: Quantum Genomics SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 7, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Males

Intervention

Drug:
• Firibastat
Firibastat (QGC001) 500 mg

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Quantum Genomics SA	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Maximum Plasma Concentration.	[Cmax]	3 months
Primary	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.	[Tmax]	3 months
Primary	Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Areas Under the Curve.	[AUC0-24, AUC0-last and AUC0-inf]	3 months
Secondary	Relative bioavailability of Firibastat (QGC001) modified release prototype tablet formulations compared to the immediate release capsule formulation	[AUC0-24 MR / AUC0-24 IR]	3 months
Secondary	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.	Basophils, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes, Mean Cell, Haemoglobin, Mean Cell Haemoglobin Concentration, Mean Cell Volume, Monocytes, Neutrophils, Platelet Count, Red Blood Cell Count, White Blood Cell Count	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing chemistry laboratory tests aggregated as number of patients outside normal ranges.	Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bicarbonate, Bilirubin (Total), Calcium, Chloride, Creatine Kinase, Gamma Glutamyl Transferase, Glucose (Fasting), Potassium, Phosphate (Inorganic), Protein (Total), Sodium, Urea	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing urinalysis aggregated as number of patients outside normal ranges.	Bilirubin, Blood, Glucose, Ketones, Leukocytes, Nitrites, pH, Protein, Specific gravity, Urobilinogen	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs	Blood pressure (mmHg)	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs	Heart rate (bpm)	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing AEs	Adverse events will be recorded from the time of providing written informed consent until discharge from the study at the follow-up visit. During each study visit the subject will be questioned directly regarding the occurrence of any adverse medical event according to the source schedule.	3 months
Secondary	Safety and tolerability of single doses of Firibastat (QGC001) by assessing Twelve-lead ECGs	P wave, T wave, QRS complex, QT interval, RR interval, PR segment, ST segment,	3 months