Skip to main content
OpenTrials
Completed

NCT Number: NCT03714685

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Firibastat

Drug

Firibastat (QGC001) 500 mg

Other names: QGC001

Primary outcomes

  1. Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Maximum Plasma Concentration.

    Time frame: 3 months

    [Cmax]

  2. 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.

    Time frame: 3 months

    [Tmax]

  3. Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Areas Under the Curve.

    Time frame: 3 months

    [AUC0-24, AUC0-last and AUC0-inf]

Secondary outcomes

  1. Relative bioavailability of Firibastat (QGC001) modified release prototype tablet formulations compared to the immediate release capsule formulation

    Time frame: 3 months

    [AUC0-24 MR / AUC0-24 IR]

  2. 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.

    Time frame: 3 months

    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. Safety and tolerability of single doses of Firibastat (QGC001) by assessing chemistry laboratory tests aggregated as number of patients outside normal ranges.

    Time frame: 3 months

    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

  4. Safety and tolerability of single doses of Firibastat (QGC001) by assessing urinalysis aggregated as number of patients outside normal ranges.

    Time frame: 3 months

    Bilirubin, Blood, Glucose, Ketones, Leukocytes, Nitrites, pH, Protein, Specific gravity, Urobilinogen

  5. Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs

    Time frame: 3 months

    Blood pressure (mmHg)

  6. Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs

    Time frame: 3 months

    Heart rate (bpm)

  7. Safety and tolerability of single doses of Firibastat (QGC001) by assessing AEs

    Time frame: 3 months

    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.

  8. Safety and tolerability of single doses of Firibastat (QGC001) by assessing Twelve-lead ECGs

    Time frame: 3 months

    P wave, T wave, QRS complex, QT interval, RR interval, PR segment, ST segment,

Sponsors and collaborators

Lead sponsor

Quantum Genomics SA

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2018
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.