A study in healthy volunteers to look at how different formulations (recipes) of the test medicine firibastat (QGC001) are taken up and broken down by the body
| ISRCTN | ISRCTN24120533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24120533 |
| EudraCT/CTIS number | 2019-003748-55 |
| IRAS number | 271848 |
| Secondary identifying numbers | QGC001/1QG5, IRAS 271848 |
- Submission date
- 15/02/2022
- Registration date
- 25/02/2022
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study will evaluate the safety (side effects), how the body processes the treatment (pharmacokinetics), and what the treatment does to the body (pharmacodynamic effects) of the drug QGC001 in healthy volunteers.
Who can participate?
Healthy volunteers aged 18 - 55 years
What does the study involve?
The study includes a 28 days screening period followed by a 7 days treatment period (participants will stay in the clinical research unit for the duration of the treatment). Af last visit will be conducted 48 hours after the last IP intake. In total, approximately 35 blood samples will be collected throughout the whole study for PK analysis. Additional samples can be collected for safety analysis at the same time as PK samples. The total amount of blood taken during the whole study, including the screening visit and follow-up will not exceed 550 mL in a 4-week period.
What are the possible benefits and risks of participating?
You will get no medical benefit from the test medicine, however development of a treatment for hypertension may benefit the population as a whole
Where is the study run from?
Quotient Sciences (UK)
When is the study starting and how long is it expected to run for?
October 2019 to March 2020
Who is funding the study?
Quantum Genomics (France)
Who is the main contact?
Sharan Sidhu, sharan.sidhu@quotientsciences.com
Contact information
Principal Investigator
Quotient Sciences
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)115 974 9000 |
|---|---|
| sharan.sidhu@quotientsciences.com |
Scientific
Quantum Genomics
33 Rue Marbeuf
Paris
75008
France
| Phone | +33 (0)1 85 34 77 70 |
|---|---|
| bruno.besse@quantum-genomics.com |
Public
Quantum Genomics
33 Rue Marbeuf
Paris
75008
France
| Phone | +33 (0)1 85 34 77 74 |
|---|---|
| mariette.codou@quantum-genomics.com |
Study information
| Study design | Single centre multiple dose non-randomised open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | A study in healthy subjects designed to evaluate the pharmacokinetic profile of firibastat (QGC001) and metabolites EC33 and QGC515 following multiple dose administration of QGC001 immediate release and modified release formulations |
| Study objectives | Evaluate the pharmacokinetic (PK) profiles of QGC001 and its metabolites, EC33 and QGC515, following multiple dose administration of QGC001 immediate release (IR) formulations and a modified release (MR) formulation in healthy subjects |
| Ethics approval(s) | Approved 02/01/2020, London - Surrey Borders REC (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 19/LO/1799 |
| Health condition(s) or problem(s) studied | Phase 1 study in healthy volonteers |
| Intervention | Three cohorts of 10 subjects were enrolled. Each cohort received one of the regimens: Cohort 1 - Regimen A - 500 mg (2 × 250 mg) QGC001 IR capsule BID on Days 1 to 6 and QD dosing on Day 7 Cohort 2 - Regimen C - 1000 mg (2 × 500 mg) QGC001 IR tablet QD for 7 days Cohort 3 - Regimen B - 1000 mg (2 × 500 mg) QGC001 MR tablet QD for 7 days For Regimen A, subjects will be dosed on the mornings and evenings (approximately 12 h apart) of Days 1 to 6 and on the morning of Day 7. For Regimens B and C, subjects will be dosed on the mornings of Days 1 to 7. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Firibastat (QGC001) |
| Primary outcome measure | Evaluation of the PK profiles for each drug: Tmax, Cmax, AUC, T1/2 and Ctau by collection of blood samples for PK at D1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 20 hours), D2 to D6 (Predose), D7 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 hours), D8 (24 and 36 hours after last intake), D9 (48 hours after last intake) |
| Secondary outcome measures | Collection of additional safety and tolerability information 1. Physical examination: Baseline + D9 (48 hours post last dose) 2. Safety Labs: Baseline + D9 3. Urinalysis: Baseline + D9 4. Vital signs: Baseline, D1 to D7 (3 and 6 hours post dose) and D9 (48 hours post last dose) 5. ECG: Baseline, D1 (3 hours post dose) D2 to D7 (Predose) and D9 (48 hours post last dose) |
| Overall study start date | 17/10/2019 |
| Completion date | 20/03/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Healthy males or healthy females of non-childbearing potential 2. Age 18 to 55 years at the time of signing informed consent 3. Body mass index of 18.0 to 32.0 kg/m² as measured at screening 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to adhere to the contraception requirements |
| Key exclusion criteria | 1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee 3. Subjects who have previously been enrolled in this study (subjects who participated in study QSC118052 are allowed) 4. History of any drug or alcohol abuse in the past 2 years 5. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type) 6. A confirmed positive alcohol breath test at screening or admission 7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission 8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months 9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative urine pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration ≥40 IU/L) 10. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 11. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator 12. Subjects with BP <90/40 mmHg at screening and pre-dose 13. Subjects with Gilbert’s Syndrome 14. Confirmed positive drugs of abuse test result 15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 16. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 19. Donation or loss of greater than 400 mL of blood within the previous 3 months 20. Subjects who are taking, or have taken, any prescribed or over-the-counter drugs or herbal remedies (other than 4 g of paracetamol per day and HRT) in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the PI 21. Failure to satisfy the investigator of fitness to participate for any other reason |
| Date of first enrolment | 13/01/2020 |
| Date of final enrolment | 11/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
33 Rue Marbeuf
Paris
75008
France
| Phone | +33 (0)1 85 34 77 70 |
|---|---|
| contact@quantum-genomics.com | |
| Website | http://www.quantum-genomics.com/en/ |
"ROR" |
https://ror.org/01eyskv76 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | No publication planned. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to there being no requirement to do so. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/10/2020 | 24/06/2022 | No | No | |
| Protocol file | version 1.0 | 17/10/2019 | 12/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
12/08/2022: Protocol file uploaded.
24/06/2022: The basic results of this trial have been uploaded as an additional file.
23/02/2022: Trial's existence confirmed by London - Surrey Borders REC
