Phase 1 study in healthy volonteers Not Applicable
Conditions
Interventions
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 D
Sponsors
Quantum Genomics (France)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Contacts
Public ContactCodou Mariette
Outcome results
None listed