Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR38-001
Study information
Scientific title
Acronym
Study hypothesis
The primary objective is to determine safety and tolerability of ascending single intravenous bolus injection doses of BR38 in healthy male volunteers. The secondary objective is to evaluate the imaging efficacy of BR38 in the myocardium and in the liver.
Ethics approval
Ethics approval submitted to Brent Medical Ethics Committee on the 29th April 2008.
Study design
Randomised, single-blind, placebo-controlled, ascending dose, single-site study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Healthy volunteers
Intervention
One first pilot volunteer will be included at a fixed dose. Thirty six volunteers will then be studied in six-dose groups of six subjects (dose range: 0.005 to 0.32 µl/kg). In each group, four volunteers will be randomly assigned to receive BR38 and two volunteers to receive placebo. Each volunteer will receive a unique intravenous administration. The total duration of volunteer participation in the study from the admission to discharge is anticipated to be five days. The procedure associated with administration will be completed within 20 minutes.
Intervention type
Drug
Phase
Phase I
Drug names
BR38
Primary outcome measure
Safety parameters. All safety parameters will be assessed from the enrolment of the patient and continue for 72 hours post dose at different time points.
Secondary outcome measures
Imaging quality. The image quality will be assessed up to one hour following the intravenous injection.
Overall trial start date
15/06/2008
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male volunteer
2. Aged at least 18 years up to 35 years
3. Has a body mass index (BMI) of approximately 18 - 29 kg/m^2 and maximum weight of 100 kg
4. Absence of patent foramen ovale is confirmed by echocardiography
5. Is in good health as determined by medical history, physical examination, neurological examination, electrocardiogram, haematology, plasma chemistry, urinalysis and serology
6. Provides written informed consent and is willing to comply with protocol requirements
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
37 healthy volunteers in total
Participant exclusion criteria
1. Has any known allergy to one or more of the ingredients of the investigational product
2. Has received an investigational compound within 30 days before admission into this study
3. Has any medical condition or other circumstances which would significantly decrease the chances obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
4. Had a clinical significant illness within 30 days preceding admission to the study
5. With no visualisation of left ventricle at basal echocardiography and/or without a good B mode ultrasound window for liver at screening
6. Is determined by the investigator that the subject is clinically unsuitable for the study
Recruitment start date
15/06/2008
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Via XXV Aprile 4
San Donato Milanese
20098
Italy
Sponsor information
Organisation
Bracco Imaging S.p.A (Italy)
Sponsor details
Via Folli 50
Milan
20134
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bracco Imaging S.p.A (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21487303
Publication citations
-
Results
Schneider M, Anantharam B, Arditi M, Bokor D, Broillet A, Bussat P, Fouillet X, Frinking P, Tardy I, Terrettaz J, Senior R, Tranquart F, BR38, a new ultrasound blood pool agent., Invest Radiol, 2011, 46, 8, 486-494, doi: 10.1097/RLI.0b013e318217b821.