Healthy Volunteers
Conditions
Brief summary
The purpose of this clinical research study is to learn the biodistribution of injection of BMS747158 at stress and assess the safety of two doses of BMS747158
Interventions
DRUGBMS747158
2 IV injection of \ 11 mCi (total) F-18 labeled compound
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-40 * BMI 18-30 kg/m2 * No active or chronic illnesses * If female: not pregnant, use of birth control or not of child-bearing potential
Exclusion criteria
* Significant active or chronic illness * Any neurological disorder * GI disease within 3 months * Recent infection * Major surgery within 4 weeks * Donation of blood within 4 weeks * Blood transfusion within 4 weeks * Recent history drug/alcohol abuse * Head trauma * Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities * Prescription or OTC drugs within 2 weeks * Exposure to any other investigational
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dosimetry analysis following whole body imaging after stress injection | Imaging takes place approximately 0 - 300 minutes post injection |
Secondary
| Measure | Time frame |
|---|---|
| Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest and stress | Screening (14 days prior to dosing) through 14 days post dose administration |
Countries
United States
Outcome results
None listed