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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00707538
First received: June 27, 2008
Last updated: August 17, 2011
Last verified: August 2011
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dana Washburn, MD, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00707538     History of Changes
Other Study ID Numbers: BMS747158-102
Study First Received: June 27, 2008
Last Updated: August 17, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014