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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014866-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Nuclear Energy Commission (CEA) | UNKNOWN |
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The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.
The aim of this study is to test the administration of combination of substrates and thereby to characterise simultaneously the main enzymes and transporters involved in drug metabolism. The doses of substrates administered will first assessed in terms of safety and their appropriateness for determination of pharmacokinetic parameters. Ten volunteers will be used, this number having been defined in view of the aims of this proof-of-concept pilot study,ie,safety and determination of pharmacokinetic parameters. The number was not the result of statistical calculation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 parents drugs adminstration | Drug | A single and concomittant administration of 10 parent drugs will be performed: Acetaminophene, cafeine, dextrometorphan, digoxin, memantine,midazolam, omeprazole, repaglinide, rosuvastatine, tolbutamide. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | The aim endpoint is based on the main pharmacokinetic parameters of each subject for all substrates and all metabolites. These main parameters are the area under the curve (AUC), the maximum concentration (Cmax), the half-life (T1/2)and the ratios of AUCs of the substrate and metabolites | one week |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of the concomittant administration of the 10 drugs: 1/number of volunteers with grade 4 adverse events 2/ number of volunteers with any adverse event, (grade 1 to grade 4) | All clinical and biological adverse events will be recorded within the 7 days following drug administration. | one week |
| pharmacokinetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DUVAL Xavier, doctor | Center of clinical investigation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of clinical investigation | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25465228 | Result | Lenuzza N, Duval X, Nicolas G, Thevenot E, Job S, Videau O, Narjoz C, Loriot MA, Beaune P, Becquemont L, Mentre F, Funck-Brentano C, Alavoine L, Arnaud P, Delaforge M, Benech H. Safety and pharmacokinetics of the CIME combination of drugs and their metabolites after a single oral dosing in healthy volunteers. Eur J Drug Metab Pharmacokinet. 2016 Apr;41(2):125-38. doi: 10.1007/s13318-014-0239-0. Epub 2014 Dec 3. |
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To determine which sampling times will provid the most pharmacokinetic information on the most compounds |
| one week |
| Genotypes | Depending on the genotypes of the volunteers included, to evaluate the influence of these genotypes ont he pharmacokinetics of the substrates and their metabolites | one month |