- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00707538
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress
November 6, 2020 updated by: Lantheus Medical Imaging
A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Los Angeles, California, United States, 90095
- UCLA Medical Center
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- John Hopkins University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
2 IV injection of ~11 mCi (total) F-18 labeled compound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dosimetry analysis following whole body imaging after stress injection
Time Frame: Imaging takes place approximately 0 - 300 minutes post injection
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Imaging takes place approximately 0 - 300 minutes post injection
|
Secondary Outcome Measures
Outcome 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
Time Frame: Screening (14 days prior to dosing) through 14 days post dose administration
|
Screening (14 days prior to dosing) through 14 days post dose administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jamshid Maddahi, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
June 27, 2008
First Submitted That Met QC Criteria
June 30, 2008
First Posted (Estimate)
July 1, 2008
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
August 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- BMS747158-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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