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

NCT ID: NCT00707538

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

BMS747158

Intervention Type DRUG

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

Interventions

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BMS747158

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamshid Maddahi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

John Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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BMS747158-102

Identifier Type: -

Identifier Source: org_study_id