A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BMS747158
- Registration Number
- NCT00707499
- Lead Sponsor
- Lantheus Medical Imaging
- Brief Summary
The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 BMS747158 -
- Primary Outcome Measures
Name Time Method Dosimetry analysis following whole body imaging after resting injection Imaging takes place 0 - 310 minutes post injection
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
UCLA Medical Center
🇺🇸Los Angeles, California, United States