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Drug Transporter Interaction Study PHENTRA_2015_KPUK

NCT02743260 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-09-10

No results posted yet for this study

Summary

The objective of the present study is to contribute to establishing in vivo phenotyping procedures for organic anionic transporter polypeptide 1B1 (OATP1B1), organic cation transporters 1 and 2 (OCT1/2), multidrug and toxic compound extrusion transporters 1 and 2,kidney splice variant (MATE1/2K), organic anion transporters 1 and 3 (OAT1/3), and p-glycoprotein (P-gp) transporters via a cocktail approach. To this end, marker substrates for each of the respective transporters are administered as single doses in one period each and as a cocktail in one period to 24 healthy volunteers, and phenotyping metrics are derived from plasma and urine concentrations.

Conditions

  • Healthy

Interventions

DRUG

pitavastatin

DRUG

Metformin

DRUG

digoxin

DRUG

Adefovir

DRUG

sitagliptin

Sponsors & Collaborators

  • Umm Al-Qura University

    collaborator OTHER

  • Institute for Biomedical and Pharmaceutical Research (IBMP), Nürnberg-Heroldsberg, Germany

    collaborator UNKNOWN

  • University of Cologne

    lead OTHER

Principal Investigators

  • Uwe Fuhr, Prof. Dr. · Department of Pharmacology I, University Hospital Cologne Cologne, NRW, Germany, 50931

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02743260 on ClinicalTrials.gov