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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS747158

• Registration Number: NCT00707538
• Lead Sponsor: Lantheus Medical Imaging

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-08
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BMS747158	-

Primary Outcome Measures

Name	Time	Method
Dosimetry analysis following whole body imaging after stress injection	Imaging takes place approximately 0 - 300 minutes post injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States