E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Liver Magnetic Resonance Imaging (MRI) in healthy volunteers |
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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 |
The primary objective is to evaluate the dose-response of three different doses of the contrast medium CMC-001 in liver MRI with regard to image quality. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to further evaluate the tolerance and safety profile of CMC-001. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1/ Provision of informed consent prior to conducting any study-related procedures. 2/ Healthy volunteer, female or male aged 18 years. 3/ Able and willing to co-operate. |
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E.4 | Principal exclusion criteria |
1)A positive laboratory test result for hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2. 2)Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using adequate acceptable contraceptive measures, as judged by the Investigator. 3)Men not using acceptable contraceptive measures, as judged by the Investigator. 4)Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the subject or the objectives of the study, as judged by the Investigator. 5)Clinically relevant abnormalities in electrocardiogram (ECG), haematology, clinical chemistry, serology or urine chemistry, as judged by the Investigator. 6)Newly discovered unstable diabetes or ongoing renal disease including haemodialysis or peritoneal dialysis. 7)Concurrent severe illness in the gastrointestinal tract like paralysis or malabsorption, or clinically manifested jaundice. 8)Known liver cirrhosis. 9)Drug or alcohol abuse by asking the subject at screening. 10)Contraindications to MR imaging (e.g. aneurysm clip, pacemaker, or severe claustrophobia). 11)Known or suspected hypersensitivity to the investigational product or excipients of the investigational product. 12)Ongoing treatment with tetracycline or doxycycline. 13)Use of antidiarrhoea or antinausea drugs during the last 7 days preceding this study. 14)Participation in another clinical study during the last 3 months preceding this study or at any time during the participation in this study. 15)Investigations involving X-ray, MRI, nuclear medicine or ultrasound using intravenous or oral contrast medium within the period of 7 days before and 7 days after each dose in this study. 16)Previous inclusion in this study. 17)Any other reason that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The increase in the ratio of liver/muscle signal before and after contrast medium administration. |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 |
Three different dose levels and each subject will be his/her own control. |
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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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Last subject, last visit (incl.the telephone follow-ups) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
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 |