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

NCT03011463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dr. R. Pfleger Chemische Fabrik GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-03-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011463 on ClinicalTrials.gov