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

• Sponsor: Lantheus Medical Imaging (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00707538
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 4
• Patients Per Site: 6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS747158	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: BMS747158; 2 IV injection of ~11 mCi (total) F-18 labeled compound

Outcome Measures

Primary Outcome Measures

1. Dosimetry analysis following whole body imaging after stress injection [Imaging takes place approximately 0 - 300 minutes post injection]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	John Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Lantheus Medical Imaging

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lantheus Medical Imaging
• ClinicalTrials.gov Identifier: NCT00707538
• Other Study ID Numbers: BMS747158-102
• First Posted: Jul 1, 2008
• Last Update Posted: Nov 10, 2020
• Last Verified: Aug 1, 2011

Study Results

No Results Posted as of Nov 10, 2020