E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
Study group 1: To gain data about radiotracer metabolism in humans. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
development of a diagnostic method for positron emission tomography |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
development of diagnostics for positron emission tomography, tariquidar adm correponds to phase III |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
comparison of the two positron emission tomography tracers [11C]elacridar and [11C]tariquidar |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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data provided in the protocol
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |