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Drug InteractionPhase 1NCT02391688

Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail

A Phase 1 study testing Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam, Bupropion and Fexofenadine in people with Drug Interaction, run by Jules Desmeules at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Drug Interaction
What is being tested?
Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam, Bupropion and Fexofenadine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSwitzerland
Study dates
Nov 2014to Apr 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers aged from 18 to 60 years
  • BMI between 18 and 27
  • Understanding of French language and able to give a written inform consent.

Who cannot join

  • smoker
  • pregnant women
  • taking drugs which alter cytochrome P450 (CYP) activity
  • renal or hepatic impairment
  • medical history of chronic alcoholism or abuse of psychoactive drugs
  • liver transplantation
Show all 9Show fewer
  • sensitivity to any of the drugs used
  • Alteration of hepatic tests, more than 2x normal (aspartate transaminase >100U/L ; alanine transaminase >100 units/L ; gamma-glutamyl transferase >80 units/L ; bilirubin >50µmol/L)
  • Presenting genetic polymorphism of poor CYP2C9, CYP2C19, CYP2D6 metabolizer

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre de Recherche Clinique, HUG, Rue Gabrielle Perret-Gentil 4

    Geneva, 1211

Other trials in Switzerland

About this study

Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. The administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and P-gp in a single test.

When a cocktail approach is used it is important to make sure that no drug-drug interactions occur between the probes within the cocktail. The validation of the lack of interactions, which is the aim of the study, consists of demonstrating that there is no difference in the pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

Probe and metabolite concentrations will be measured in capillary blood using a dried blood spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to ensure the precision of capillary blood collection.

Being tested
Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam, Bupropion, Fexofenadine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolamDrug

  • BupropionDrug

  • FexofenadineDrug

Study groups in NCT02391688
Study groupRoleWhat they receive
Treatment AExperimentalOral intake of: caffeine 50 mg dextromethorphan 10 mg omeprazole 10 mg flurbiprofen 10 mg midazolam 1 mg
Receives: Drug: Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam
Treatment BExperimentalOral intake of: fexofenadine 25 mg
Receives: Drug: Fexofenadine
Treatment CExperimentalOral intake of: bupropion 20 mg
Receives: Drug: Bupropion
Treatment DExperimentalOral Intake of Geneva cocktail (A+B+C): caffeine 50 mg dextromethorphan 10 mg omeprazole 10 mg flurbiprofen 10 mg midazolam 1 mg fexofenadine 25 mg bupropion 20 mg
Receives: Drug: Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam; Drug: Bupropion; Drug: Fexofenadine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the capillary blood concentration-time curve (AUC) of caffeine

    Comparison of caffeine AUC when treatment A or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  2. Area under the capillary blood concentration-time curve (AUC) of dextromethorphan

    Comparison of dextromethorphan AUC when treatment A or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  3. Area under the capillary blood concentration-time curve (AUC) of flurbiprofen

    Comparison of flurbiprofen AUC when treatment A or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  4. Area under the capillary blood concentration-time curve (AUC) of midazolam

    Comparison of midazolam AUC when treatment A or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  5. Area under the capillary blood concentration-time curve (AUC) of omeprazole

    Comparison of omeprazole AUC when treatment A or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  6. Area under the capillary blood concentration-time curve (AUC) of fexofenadine

    Comparison of fexofenadine AUC when treatment B or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment B or D

  7. Area under the capillary blood concentration-time curve (AUC) of bupropion

    Comparison of bupropion AUC when treatment C or D is administered

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post treatment C or D

Secondary outcomes (7)

  1. Metabolic ratio (MR) of paraxanthine blood concentration /caffeine blood concentration

    Comparison of paraxanthine/caffeine MRs between treatment A and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  2. Metabolic ratio (MR) of dextrorphan blood concentration /dextromethorphan blood concentration

    Comparison of dextrorphan/dextromethorphan MRs between treatment A and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  3. Metabolic ratio (MR) of 4-hydroxyflurbiprofen blood concentration /flurbiprofen blood concentration

    Comparison of 4-hydroxyflurbiprofen/flurbiprofen MRs between treatment A and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  4. Metabolic ratio (MR) of 1-hydroxymidazolam blood concentration /midazolam blood concentration

    Comparison of 1-hydroxymidazolam/midazolam MRs between treatment A and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  5. Metabolic ratio (MR) of 5-hydroxyomeprazole blood concentration /omeprazole blood concentration

    Comparison of 5-hydroxyomeprazole/omeprazole MRs between treatment A and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D

  6. Metabolic ratio (MR) of 4-hydroxybupropion blood concentration /bupropion blood concentration

    Comparison of 4-hydroxybupropion/bupropion MRs between treatment C and D

    Measured: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post treatment C or D

  7. Number of adverse events

    Measured: at each drug administration day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391688
Sponsor's protocol ID
14-061
Status last verified
Feb 2017
First submitted
19 Feb 2015
Last updated
7 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam, Bupropion and Fexofenadine in people with Drug Interaction, run by Jules Desmeules at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the capillary blood concentration-time curve (AUC) of caffeine (time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post treatment A or D). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02391688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.

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