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

November 6, 2020 updated by: Lantheus Medical Imaging

A Single-Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of BMS 747158 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 drug/device within 6

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Single dose administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dosimetry analysis following whole body imaging after resting injection
Time Frame: Imaging takes place 0 - 310 minutes post injection
Imaging takes place 0 - 310 minutes post injection

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Screening (14 days prior to dosing) through 14 days post dose administration
Screening (14 days prior to dosing) through 14 days post dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 1, 2008

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • BMS747158-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on BMS747158

3
Subscribe