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A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707538
First Posted: July 1, 2008
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lantheus Medical Imaging
  Purpose
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

Condition Intervention Phase
Healthy Volunteers Drug: BMS747158 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Dosimetry analysis following whole body imaging after stress injection [ Time Frame: Imaging takes place approximately 0 - 300 minutes post injection ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BMS747158
2 IV injection of ~11 mCi (total) F-18 labeled compound

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707538


Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Principal Investigator: Jamshid Maddahi, MD University of California, Los Angeles
  More Information

Responsible Party: Dana Washburn, MD, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00707538     History of Changes
Other Study ID Numbers: BMS747158-102
First Submitted: June 27, 2008
First Posted: July 1, 2008
Last Update Posted: August 18, 2011
Last Verified: August 2011