Status:
UNKNOWN
Risk of CYP2C19 Phenoconversion in Healthy Volunteers With Rapid, Normal, and Intermediate Predicted Metabolizers' Status
Lead Sponsor:
University Hospital, Geneva
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
CYP2C19 is responsible for the metabolism of approximately 10% of drugs currently on the market, including several proton pump inhibitors, clopidogrel, benzodiazepines and some tricyclic antidepressan...
Detailed Description
Phase 1, open-label, parallel study in healthy volunteers selected according to their genotypic belonging to one of the three study groups. Volunteers are included in the study and go through a bucca...
Eligibility Criteria
Inclusion
- Healthy men and women ≥ 18 years old
- Understanding of French language and able to give a written consent
- Reliable contraception during the whole study, including a barrier method
- CYP2C19 genotype associated to the RM (\*1/\*17) , NM(\*1/\*1) AND IM(\*1/\*2-\*2/\*17) activity groups
Exclusion
- Participation in any other interventional clinical study within 3 months prior to inclusion
- Pregnant or breastfeeding woman
- Any pathologies, use of drugs or food that may affect CYP activity (based on the "drug interactions and cytochromes P450" table published by the service of Clinical Pharmacoloy and Toxicology, HUG and on the investigator's knowledge)
- History of liver transplantation
- Alcohol intake during fluvoxamine intake
- Psychotropic substances use during fluvoxamine intake
- Alteration of hepatic tests (ASAT, ALAT, GGT, BILI) more than 3x normal
- Glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2
- Medical history of chronic alcoholism or abuse of psychoactive drugs
- Regular use of psychotropic substances
- Sensitivity to any of the drugs used
- Psychiatric disorders
- Beck Score ≥ 10 (question related to suicide \>0)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05264142
Start Date
April 1 2022
End Date
August 31 2023
Last Update
November 3 2022
Active Locations (1)
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1
Geneva University Hospitals, HUG
Geneva, Switzerland