Development of Cocktail for Measuring the Activity of Important Cytochrome P450 Enzymes
NCT ID: NCT00981929
Last Updated: 2010-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
412 participants
INTERVENTIONAL
2009-09-30
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The drugs tramadol, omeprazole, losartan, quinidine and caffeine reflect the activity of CYP2D6 (tramadol), CYP2C19 (omeprazole), CYP2C9 (losartan), CYP1A2 (caffeine) and CYP3A4/5 (quinidine).
The aim of the study is to investigate if the cocktail of tramadol, omeprazole, losartan and caffeine can be used to simultaneously determine the activity of CYP2D6, CYP2C19, CYP2C9 and CYP1A2. Furthermore, will the natural occurring 4-beta-hydroxy-cholesterol in the blood be measured as a metric for CYP3A4/5.
The study is divided in two. First part will include 12 healthy volunteers and consists of three arms separated by at least one week. In the first arm 50 mg of tramadol will be ingested and urine will be collected for 8 hours. In the second arm 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs. In the last arm 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs.
Metabolic ratios will be calculated based on urine and plasma concentrations of the drugs and the relevant metabolites. Relevant genetic variants of the cytochrome P450 encoding genes will be determined.
If the metabolic ratios of the drugs are not significantly different between the arms, Second part of the study will be conducted.
This part is identical with the last arm and will include a maximum of 400 healthy volunteers: 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)
NCT03979989
CYP2C19 Variants and Limonene Metabolism
NCT05078723
Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole
NCT03092193
Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?
NCT00732966
Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6
NCT03054220
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tramadol
CYP2D6 metric
Tramadol
50 mg single oral dose
Omeprazole, losartan, caffeine
CYP2C19, CYP2C9 and CYP1A2 metrics
Omeprazole, losartan, caffeine
20 mg omeprazole 25 mg losartan 200 mg caffeine
Tramadol, omeprazole, losartan and caffeine
CYP2D6, CYP2C19, CYP2C9 and CYP1A2 metrics
Tramadol, omeprazole, losartan, caffeine
50 mg tramadol 20 mg omeprazole 25 mg losartan 200 mg caffeine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tramadol
50 mg single oral dose
Omeprazole, losartan, caffeine
20 mg omeprazole 25 mg losartan 200 mg caffeine
Tramadol, omeprazole, losartan, caffeine
50 mg tramadol 20 mg omeprazole 25 mg losartan 200 mg caffeine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written consent, AND
* Age 18-65 years old.
Exclusion Criteria
* Alcohol abuse,
* Pregnancy, OR
* Breastfeeding.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Southern Denmark, Clinical Pharmacology
Odense, Fyn, Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pedersen RS, Damkier P, Christensen MM, Brosen K. A cytochrome P450 phenotyping cocktail causing unexpected adverse reactions in female volunteers. Eur J Clin Pharmacol. 2013 Dec;69(12):1997-9. doi: 10.1007/s00228-013-1561-1. Epub 2013 Aug 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AKF-375
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.