NCT03714685

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

September 26, 2018

Last Update Submit

June 17, 2019

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (3)

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

    \[Cmax\]

    3 months

  • 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

  • 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 Outcomes (8)

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

    3 months

  • 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.

    3 months

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

    3 months

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

    3 months

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

    3 months

  • +3 more secondary outcomes

Study Arms (1)

Firibastat prototype tablet formulations

EXPERIMENTAL

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

Drug: Firibastat

Interventions

FiribastatDRUG

Firibastat (QGC001) 500 mg

Also known as: QGC001
Firibastat prototype tablet formulations

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 18.0 to 32.0 kg/m2
  • Must adhere to the contraception requirements

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

firibastat

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 22, 2018

Study Start

February 15, 2019

Primary Completion

May 15, 2019

Study Completion

June 7, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

GB(1)