Healthy
Conditions
Brief summary
The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.
Interventions
DRUGBMS747158
Single dose administration.
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 drug/device within 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dosimetry analysis following whole body imaging after resting injection | Imaging takes place 0 - 310 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 | Screening (14 days prior to dosing) through 14 days post dose administration |
Countries
United States
Outcome results
None listed