Safety and pharmacokinetics of the CIME combination of drugs and their metabolites after a single oral dosing in healthy volunteers

التفاصيل البيبلوغرافية
العنوان:	Safety and pharmacokinetics of the CIME combination of drugs and their metabolites after a single oral dosing in healthy volunteers
المؤلفون:	Lenuzza, Natacha, Duval, Xavier, Nicolas, Grégory, Thévenot, Etienne, Job, Sylvie, Videau, Orianne, Narjoz, Céline, Loriot, Marie-Anne, Beaune, Philippe, Becquemont, Laurent, Mentré, France, Funck-Brentano, Christian, Alavoine, Loubna, Arnaud, Philippe, P., Delaforge, Marcel, Bénech, Henri
المساهمون:	Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Centre d'investigation Clinique CHU Bichat - Épidémiologie clinique (CIC 1425), AP-HP - Hôpital Bichat - Claude Bernard Paris, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Médecine Personnalisée, Pharmacogénomique, Optimisation Thérapeutique (MEPPOT - U1147), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Européen Georges Pompidou APHP (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre, Barrière et passage des médicaments, Université Paris-Sud - Paris 11 (UP11)-IFR141, Centre d'investigation clinique Paris Est CHU Pitié Salpêtrière (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition CHU Pitié Salpêtrière (IHU ICAN), CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'Investigations Cliniques CHU Bichat (CIC plurithématique), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Systèmes membranaires, photobiologie, stress et détoxification (SMPSD - UMR 8221), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)
المصدر:	ISSN: 0378-7966.
بيانات النشر:	HAL CCSD Springer
سنة النشر:	2016
مصطلحات موضوعية:	IN-VIVO, COCKTAIL APPROACH, P-GLYCOPROTEIN, PHARMACODYNAMIC INTERACTIONS, INTERINDIVIDUAL VARIABILITY, GLUCURONIDATION PARAMETERS, PARACETAMOL ACETAMINOPHEN, DIGOXIN PHARMACOKINETICS, Signal processing, CIME, Probes, Phase I, Pharmacokinetics, Safety, HIV-INFECTED PATIENTS, TRANSPORTING POLYPEPTIDE 1B1, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
الوصف:	International audience ; This phase I, pilot clinical study was designed to evaluate the safety and the pharmacokinetic (PK) profiles of the CIME (Metabolic Identity Card) combination of ten drugs, with a view to its use as a phenotyping cocktail. Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19, dextromethorphan-CYP2D6, midazolam-CYP3A, acetaminophen-UGT1A1, 6&9 and 2B15, digoxin-P-gp, rosuvastatin-OATP1B1&3 and memantine-active renal transport). Blood was collected over 3 days and on day 7. CIME probes and relevant metabolites were assayed by LC-MS/MS and PK parameters were calculated. Main results were: (1) good safety with reversible mild or moderate adverse effects, (2) an analytical method able to quantify simultaneously the 10 probes and the major metabolites, (3) calculation of PK parameters for all probes in general agreed with published values, and (4) identification of the low CYP2D6 metabolizer. This pilot study showed that the CIME combination was well tolerated and that its pharmacokinetics could be accurately measured in healthy volunteers. This combination can now confidently be checked for sensitivity and specificity and for lack of interaction to be validated as a phenotyping cocktail.
نوع الوثيقة:	article in journal/newspaper
اللغة:	English
ردمك:	978-0-00-376251-8 0-00-376251-3
العلاقة:	info:eu-repo/semantics/altIdentifier/pmid/25465228; hal-01868750; https://hal.science/hal-01868750Test; https://hal.science/hal-01868750/documentTest; https://hal.science/hal-01868750/file/article_NatachaLenuzza_EJDMP.pdfTest; PUBMED: 25465228; WOS: 000376251300004
DOI:	10.1007/s13318-014-0239-0
الإتاحة:	https://doi.org/10.1007/s13318-014-0239-0Test https://hal.science/hal-01868750Test https://hal.science/hal-01868750/documentTest https://hal.science/hal-01868750/file/article_NatachaLenuzza_EJDMP.pdfTest
حقوق:	http://hal.archives-ouvertes.fr/licences/copyrightTest/ ; info:eu-repo/semantics/OpenAccess
رقم الانضمام:	edsbas.7D70C22C
قاعدة البيانات:	BASE

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الوصف
ردمك:	9780003762518 0003762513
DOI:	10.1007/s13318-014-0239-0