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

Lantheus Medical Imaging

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BMS747158

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707499

BMS747158-101

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Treatment:

Drug: BMS747158