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

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00707538

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
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 ]

Estimated 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
1: Experimental	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

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, MD, MPH )
Study ID Numbers:	BMS-747158-102
Study First Received:	June 27, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00707538
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Stress
Healthy

ClinicalTrials.gov processed this record on January 16, 2009