Safety and tolerability of BR38 in healthy volunteers: a phase I study
| ISRCTN | ISRCTN39269910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39269910 |
| Protocol serial number | BR38-001 |
| Sponsor | Bracco Imaging S.p.A (Italy) |
| Funder | Bracco Imaging S.p.A (Italy) |
- Submission date
- 13/05/2008
- Registration date
- 15/05/2008
- Last edited
- 12/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniela Bokor
Scientific
Scientific
Via XXV Aprile 4
San Donato Milanese
20098
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single-blind, placebo-controlled, ascending dose, single-site study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval submitted to Brent Medical Ethics Committee on the 29th April 2008. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | BR38 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Imaging quality. The image quality will be assessed up to one hour following the intravenous injection. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Male |
| Target sample size at registration | 37 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/06/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- Italy
Study participating centre
Via XXV Aprile 4
San Donato Milanese
20098
Italy
20098
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
