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NCT01624246 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
A Phase 1 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01624246: Completed Phase 1 study, sponsored by Forest Laboratories.
NCT01624246 is a Phase 1 study that has completed, run by Forest Laboratories. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624246, a Phase 1 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
Primary Outcome
The following PK parameters, if calculable, will be determined for ceftaroline, ceftaroline fosamil, ceftaroline M-1, and avibactam: area under the plasma concentration versus time curve, Cmax, time of maximum plasma drug concentration (Tmax), T½, apparent total body clearance of drug from plasma (CL), apparent volume of distribution during the terminal phase (Vz), and Vss.
Interventions
- DRUG Ceftaroline fosamil/Avibactam (CXL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01624246 record still lists
NCT01624246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Ceftaroline fosamil/Avibactam (CXL) is the first listed.
NCT01624246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01624246 about?
NCT01624246 is a clinical study titled "Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance". To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
What is the current status of trial NCT01624246?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01624246?
The interventions under investigation include: Ceftaroline fosamil/Avibactam (CXL) (DRUG).
Who is sponsoring clinical trial NCT01624246?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01624246's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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