To study the influence of drug transporters on the distribution of erlotinib in different organs of the human body

Phase 1

• Conditions: Investigation in volunteers only; Therapeutic area: Body processes [G] - Chemical Phenomena [G02]

• Registration Number: EUCTR2015-001593-18-AT
• Lead Sponsor: Medizinische Universiät Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-21
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

•Non-smokers
•Age: >18 and < 55 years old
•No disease interfering with the study objectives (at investigators´ discretion)
•Normotensive after 5 min rest
•Normofrequent after 5 min rest
•No contraindication for MRI
•No known hypersensitivity to any of the components of the administered substances and diagnostics
•Volunteers must sign the informed consent prior to inclusion in the study

•Inclusion criteria for patients of group 5 only:
oAbility to comprehend the full nature and purpose of the study, including possible risks and side effects
oPatients with an intrahepatic shunt undergoing measurement of portosystemic pressure gradient to assess shunt function for clinical routine purposes (one previous measurement is required)
oModerate nicotine consumption is allowed for this group

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 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Smokers
•Abnormalities found in blood and urine laboratory tests as part of the pretreatment screening or in any of the laboratory tests performed that the investigator considers clinically relevant
•Presence of any ECG abnormalities, which the investigator considers clinically relevant
•Abnormalities in the medical history (e.g. history of or current ethanol abuse, allergies, co-morbidities, anticoagulation with Marcoumar®) that might influence the outcome of the study or might result in inacceptable risks for the subject according to investigators judgment.
•History of drug and alcohol abuse
•Contraindication to arterial cannulation (e.g. intake of anticoagulants of any kind)
•Blood donation within 1 month before the start of the study
•Participation in a clinical study with radioactive substances if exposure exceeds the maximum foreseen radiation of the current guidelines
•Intake of any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4, ABCB1 or ABCG2 (ABCB1 inducers such as St. John’s wort, docetaxel, etoposide, vincristine, cyclosporine, tacrolimus, macrolides, lovastatin, digoxin, digitoxin, carvedilol, rifampicin or inhibitors such as esomprazol, omeprazole, pantoprazole, lansoprazole, atorvastatin, itraconazol) or may cause potential harm to the subject (drug-drug interaction between tariquidar and loperamide or quinidine)
•Subjects with Galactose-Intolerance, Lactase-Deficiency or Glucose-Galactose –Malabsorption (erlotinib tablets contain lactose)
•For female subjects in child-bearing age: Pregnancy or breastfeeding
•Exclusion criteria for patients of group 5 only:
oA medical condition or drug treatment interfering with the study objectives (at investigators´ discretion)
oAbsolute contraindication for PET/MRI investigation
oPatients with history of alcohol abuse who are currently abstinent
oPresence of any ECG or other abnormalities, which the investigator considers clinically relevant
oParticipation in a clinical study with radioactive substances if exposure exceeds the maximum foreseen radiation of the current guidelines

Study & Design

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