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

Lantheus Medical Imaging13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BMS747158DRUG

Single dose administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCLA Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Dosimetry analysis following whole body imaging after resting injection

Time frame: Imaging takes place 0 - 310 minutes post injection

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.