NCT07014930 Identification of New Tools for Predicting Natural Metabolic Performance of the Liver
| NCT ID | NCT07014930 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Caroline Samer |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-12-05 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this clinical trial is to identify endogenous compounds (substances naturally present in the human body) that may serve as predictors of the activity of a key liver enzyme, CYP2C19. This enzyme plays a crucial role in the metabolism of several important drugs and exhibits significant interindividual variability in its activity, which can contribute to adverse drug reactions or reduced therapeutic efficacy. The study will involve 40 healthy volunteers, divided into two groups: 10 poor metabolizers and 30 non-poor metabolizers. Each participant will undergo three sessions. In the first session, 24-hour urine collection and plasma sampling will be conducted. Omeprazole will be administered orally, and the baseline blood OH-omeprazole/omeprazole ratio will be determined via capillary blood sampling. The second session, identical in procedure to the first, will take place after 7 days of fluvoxamine administration (inhibition phase). The third session will also mirror the first but will follow 10 days of rifampicin administration (induction phase). Endogenous compounds showing significant variation across sessions and between metabolizer groups will be evaluated as potential biomarkers for predicting CYP2C19 activity.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07014930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07014930 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07014930 currently recruiting?
Yes, NCT07014930 is actively recruiting participants. Contact the research team at yahia.bennani@hug.ch for enrollment information.
Where is the NCT07014930 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT07014930 clinical trial?
NCT07014930 is sponsored by Caroline Samer. The trial plans to enroll 40 participants.