healthy volunteers
Conditions
Interventions
Product Name: Tariquidar
Product Code: Tariquidar
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: tariquidar
Current Sponsor code: XR9576
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Sex: female and male • Age: 18-55 years old • Normotensive after 5 min rest in a supine position • Normofrequent after 5 min rest in a supine position • 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 • Study group 1 only: no contraindication for MRI • Study group 2 only: weight: 60 – 85 kg and height: 170 – 185 cm 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • QTc > 450 msec or presence of any other ECG abnormality which the investigator considers clinically relevant • Intake of any medication (except contraceptives for female subjects) 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 and/or P-glycoprotein • Participation in the evaluation of any drug within four weeks before the study day. • History of drug and alcohol abuse, tobacco (> 10 cigarettes/ day) allowed • Blood donation within 3 months before the start of the study • Participation in a clinical study with a radioactive substance in the last 12 months • Pregnancy or breastfeeding (female subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study group 1: To assess the utility of [11C]elacridar and [11C]tariquidar for the visualization of P-gp at the human blood-brain barrier. Study group 2: To gain data about whole body biodistribution and organ wise radiation dosimetry of [11C]elacridar and [11C]tariquidar in humans. ;Secondary Objective: Study group 1: To gain data about radiotracer metabolism in humans.;Primary end point(s): Study group 1: Brain time-activity curves of [11C]elacridar, [11C]tariquidar and (R)-[11C]verapamil before and after infusion of 4 mg/kg body weight tariquidar. Study group 2: [11C]elacridar and [11C]tariquidar radiation dose in different organs, normalized to injected dose and expressed as mSv/MBq. | — |
Countries
Austria
Outcome results
None listed