NCT03011463

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

Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subjects Genotyped for OCT1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. R. Pfleger Chemische Fabrik GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics
• Inhibition Enzyme
• Drug Interaction Potentiation

Interventions

Type	Name	Description
DRUG	intravenous infusion of 2 mg trospium chloride	intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o
DRUG	oral administration of 30 mg trospium chloride	oral administration of 30 mg trospium chloride with 240 ml tap water
DRUG	oral administration of 300 mg ranitidine	oral administration of 300 mg ranitidine with 240 ml tap water
DRUG	oral administration of 500 mg clarithromycin	oral administration of 500 mg clarithromycin with 240 ml tap water

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-01-05
• Last updated: 2017-04-10