drugset / Trial / NCT03011463

Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1

NCT03011463

Phase 1 Completed 24 enrolled Dr. R. Pfleger Chemische Fabrik GmbH
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of the study is: * to determine absolute bioavailability, input rates, distribution volume, renal and intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 * to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor ranitidine * to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin * to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin.

Timeline

Start
2016-11
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clarithromycin Small molecule 500 mg Oral
Comparator Ranitidine Unknown 300 mg Oral
Comparator Trospium Small molecule 2 mg Intravenous
Comparator Trospium Small molecule 30 mg Intravenous

Indications

No indication recorded.