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

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ClinicalTrials.gov Identifier: NCT03714685
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
Quantum Genomics SA

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).


Condition or disease Intervention/treatment Phase
Healthy Males Drug: Firibastat Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : June 7, 2019

Arm Intervention/treatment
Experimental: Firibastat prototype tablet formulations
Firibastat (QGC001) 500 mg modified release prototype tablet formulations or immediate release capsule formulation - 1 tablet or 1 capsule administered per period
Drug: Firibastat
Firibastat (QGC001) 500 mg
Other Name: QGC001




Primary Outcome Measures :
  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 Outcome Measures :
  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,



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714685


Locations
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United Kingdom
Quotient Sciences
Nottingham, United Kingdom
Sponsors and Collaborators
Quantum Genomics SA
Quotient Sciences

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Responsible Party: Quantum Genomics SA
ClinicalTrials.gov Identifier: NCT03714685     History of Changes
Other Study ID Numbers: QGC001-1QG3
QSC118052 ( Other Identifier: Quotient Sciences )
2018-001909-89 ( EudraCT Number )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No