A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158

NCT00707499 | Completed Phase 1 DMC

• 1 other identifier: BMS747158-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Dosimetry analysis following whole body imaging after resting injection

  Imaging takes place 0 - 310 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

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

Study Arms (1)

1

EXPERIMENTAL

Drug: BMS747158

Interventions

BMS747158 DRUG

Single dose administration.

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 drug/device within 6

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, 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: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 10, 2020

Record last verified: 2011-10

Locations

US (1)