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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: Completed Phase 1 study, sponsored by GE Healthcare.
NCT01004770 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
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 |
What the finished NCT01004770 record still lists
NCT01004770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which GE-145 (AN113111) Injection is the first listed.
NCT01004770 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004770's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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