Condition category
Not Applicable
Date applied
13/05/2008
Date assigned
15/05/2008
Last edited
12/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniela Bokor

ORCID ID

Contact details

Via XXV Aprile 4
San Donato Milanese
20098
Italy

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 measures

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

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

http://www.bracco.com/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21487303

Publication citations

  1. 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.

Additional files

Editorial Notes