Healthy volunteers Not Applicable
Conditions
Interventions
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 volunte
Sponsors
Bracco Imaging S.p.A (Italy)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Imaging quality. The image quality will be assessed up to one hour following the intravenous injection. | — |
Countries
United Kingdom
Outcome results
None listed