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NCT01004770 · ClinicalTrials.gov registry record · Phase 1
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
A Phase 1 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01004770 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 50 participants.
The verdict
NCT01004770, a Phase 1 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.
Interventions
- DRUG GE-145 (AN113111) Injection
- DRUG Visipaque (iodixanol) Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004770
The ClinicalTrials.gov registry entry for NCT01004770 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GE-145 (AN113111) Injection is the first listed.
NCT01004770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01004770 about?
NCT01004770 is a clinical study titled "Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)". This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs)...
What is the current status of trial NCT01004770?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2009-10. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01004770?
The interventions under investigation include: GE-145 (AN113111) Injection (DRUG), Visipaque (iodixanol) Injection (DRUG).
Who is sponsoring clinical trial NCT01004770?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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