Drug Transporter Interaction Study PHENTRA_2015_KPUK

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cologne
• Collaborators: Institute for Biomedical and Pharmaceutical Research (IBMP), Nürnberg-Heroldsberg, Germany; Umm Al-Qura University
• Treatments: Adefovir; Adefovir dipivoxil; Digoxin; Metformin; Pitavastatin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Caucasian

• Body mass index (BMI) between and inclusive 18.5 and 30 kg/m2

• Willing and capable to confirm written consent prior to enrolment after ample information has been provided

• Normal findings in the medical history unless the principal investigator considers an abnormality to be clinically relevant.

• Considered to be healthy by the principal investigator on the basis of extensive pre-study screening-

Exclusion Criteria:

Standard for healthy volunteers, including:

• Female subjects only: positive results in pregnancy test

• Female subjects only: lactating women

• Female subjects only: subjects who do not use or do not agree to use appropriate contraceptive methods during the study as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CHMP/ICH/286/95 modification)