A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158 - Full Text View

Purpose

The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.

Condition	Intervention	Phase
Healthy	Drug: BMS747158	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Subject), Single Group Assignment, Bio-availability Study

Official Title:	A Single-Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of BMS 747158 in Healthy Subjects

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

Dosimetry analysis following whole body imaging after resting injection [ Time Frame: Imaging takes place 0 - 310 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 [ Time Frame: Screening (14 days prior to dosing) through 14 days post dose administration ] [ Designated as safety issue: Yes ]

Enrollment:	13
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: BMS747158

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707499

Locations


United States, California
	UCLA Medical Center
	Los Angeles, California, United States, 90095

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators


Principal Investigator:	Jamshid Maddahi, MD	University of California, Los Angeles

More Information

Responsible Party:	Lantheu Medical Imaging ( Qi Zhu, MD, MPH )
Study ID Numbers:	BMS-747158-101
First Received:	June 27, 2008
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00707499
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00707499