Finding natural blood and urine markers that predict how your liver metabolizes drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-centre, open-label Phase 1 trial will enroll 40 healthy adults at Geneva University Hospitals and divide them into 10 poor metabolizers and 30 non-poor metabolizers by CYP2C19 genotype. Each participant will complete three sessions: baseline phenotyping after a single 10 mg oral dose of omeprazole, an inhibition phase after 7 days of fluvoxamine, and an induction phase after rifampicin, with 24-hour urine collections and plasma and extracellular vesicle sampling at each session. Untargeted metabolomic profiling using UHPLC-HRMS will be performed on plasma, extracellular vesicles, and urine to search for endogenous compounds associated with CYP2C19 activity. The protocol compares genetic, inhibited, and induced enzyme states to identify candidate endogenous biomarkers that could serve as non-invasive phenotyping tools.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy men and women
* Age 18-65 years
* Body Mass Index (BMI) 18-27
* Understanding of French language and able to give a written inform consent
* CYP2C19 genotype: PMs, NMs, RMs or UMs
* At least one barrier method contraception during the whole study and 1 month after the end of the study (in addition of hormonal contraception if applicable)

Exclusion Criteria:

* CYP2C19 IMs
* 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 Pharmacology and Toxicology, HUG50 and on the investigator's knowledge)
* Medical history of liver transplantation
* Regular smokers of ≥ 10 cigarettes/day
* Alcohol intake 2 days prior to session 1 and during fluvoxamine and rifampicin intake
* Alteration of hepatic tests (ASAT, ALAT, GGT, bilirubin more than 3x normal)
* Renal failure (serum urea, serum creatinine and eGFR outside the norms)
* Medical history of chronic alcoholism or abuse of psychoactive drugs
* Sensitivity to any of the drugs used
* Psychiatric disorders
* Beck Score ≥10 (question related to suicide \>0)
* Contact lens wearers

Where it's running

• The Geneva University Hospitals (HUG)
  Geneva, Switzerland Recruiting

Study contacts

• Study coordinator: Yahia Bennani, Master's degree
• Email: yahia.bennani@hug.ch
• Phone: +41 78 733 14 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.