NCT00707538

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 10, 2020

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

June 27, 2008

Last Update Submit

November 6, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Dosimetry analysis following whole body imaging after stress injection

    Imaging takes place approximately 0 - 300 minutes post injection

Secondary Outcomes (1)

  • 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

    Screening (14 days prior to dosing) through 14 days post dose administration

Study Arms (1)

1

EXPERIMENTAL
Drug: BMS747158

Interventions

BMS747158DRUG

2 IV injection of \~11 mCi (total) F-18 labeled compound

1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

BMS 747158-02

Study Officials

  • Jamshid Maddahi, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 1, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 10, 2020

Record last verified: 2011-08

Locations

US(2)