ISRCTN24120533
Completed
Phase 1
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
Quantum Genomics (France)0 sites30 target enrollmentFebruary 25, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Quantum Genomics (France)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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