Pharmacokinetic Study to Characterize Individual Metabolic Profile

Phase 1 Completed 10 enrolled French National Institute of Health and Medical Research Nuclear Energy Commission (CEA) · collab

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2010-08
Primary completion: 2011-07
Completion: 2011-07

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	—	Oral
Subject	Caffeine	Small molecule	—	Oral
Subject	Dextromethorphan	Unknown	—	Oral
Subject	Digoxin	Other / unclassified	—	Oral
Subject	Memantine	Unknown	—	Oral
Subject	Midazolam	Small molecule	—	Oral
Subject	Omeprazole	Other / unclassified	—	Oral
Subject	Repaglinide	Small molecule	—	Oral
Subject	Rosuvastatin	Small molecule	—	Oral
Subject	Tolbutamide	Small molecule	—	Oral

Indications

No indication recorded.