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Completed

NCT Number: NCT00707538

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS747158

Drug

2 IV injection of ~11 mCi (total) F-18 labeled compound

Primary outcomes

  1. Dosimetry analysis following whole body imaging after stress injection

    Time frame: Imaging takes place approximately 0 - 300 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 and stress

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

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 1, 2008
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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