Evaluation of the imaging quality of CMC-001(manganese chloride tetrahydrate) in liver Magnetic Resonance Imaging (MRI) in healthy volunteers. A double-blind, randomized cross-over, dose-response study

• Conditions: iver Magnetic Resonance Imaging (MRI) in healthy volunteers

• Registration Number: EUCTR2009-010422-20-SE
• Lead Sponsor: CMC Contrast AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: The secondary objective is to further evaluate the tolerance and safety profile of CMC-001.;Primary end point(s): The increase in the ratio of liver/muscle signal before and after contrast medium administration.