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

Healthy Volunteers Clinical Trial

Official title:

A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707538
• Other study ID #: BMS747158-102
• Status: Completed
• Phase: Phase 1
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS747158
2 IV injection of ~11 mCi (total) F-18 labeled compound

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
United States	UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetry analysis following whole body imaging after stress injection		Imaging takes place approximately 0 - 300 minutes post injection
Secondary	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