A pilot study to assess the impact of genetic polymorphisms in the ABCB1 and ABCG2 genes on brain and organ penetration of dual Pgp/BCRP substrates in humans.

Phase 1

• Conditions: The effect of genetic polymorphisms on drug distribution will be investigated in healthy volunteers; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2012-005796-14-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-19
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Sex: female and male
•Age: 18 - 65 years old
•Normotensive after 5 min rest in a supine position
•Normofrequent after 5 min rest in a supine position
•No disease interferring with the study objectives (at investigators discretion)
•Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
•Volunteers must sign the informed consent prior to inclusion in the study
•No contraindication for MRI

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any abnormality found as part of the pretreatment screening or in any of the laboratory tests performed that the investigators considers clinically relevant
•Presence of any other ECG abnormality which the investigator considers clinically relevant
•Intake of any medication, which the investigator considers may affect the validity of the study, due to interference with CYP3A4, Pgp or BCRP (Pgp inductors such as St. John’s wort, rifampicin or inhibitors such as esomeprazol, omeprazol, pantoprazol, lansoprazol, atrovastatin, itraconazol) or may cause potential harm to the subject (e.g. drug-drug interaction between tariquidar and loperamide or quinidine)
•Contraindication to arterial cannulation (e.g. treatment with anticoagulants such as phenprocoumon or LMW heparines).
•Participation in the evaluation of any drug within two weeks before the study day.
•History of drug and alcohol abuse.
•Blood donation within 1 month before the start of the study
•Participation in clinical studies with exposure to radiation exceeding the allowed maximum foreseen by the current guidelines (http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/136_en.pdf).
•Pregnancy or breastfeeding (female subjects)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified