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NCT04486625 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT04486625: Completed Phase 1 study, sponsored by Pfizer.
NCT04486625 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486625, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.
Primary Outcome
AUC0-24,ss of ATM in Cohort 1 was calculated by 4\*AUC0-tau (tau = 6 hours), where AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). AUC0-24,ss of ATM in Cohort 2 was calculated by 3\*AUC0-tau (tau = 8 hours), where AUC0-tau was area under the plasma concentration-time profile from time 0 to time tau (the dosing interval).
Interventions
- DRUG Aztreonam-Avibactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 1 |
What the finished NCT04486625 record still lists
NCT04486625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Aztreonam-Avibactam is the first listed.
NCT04486625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04486625 about?
NCT04486625 is a clinical study titled "Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment". This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed do...
What is the current status of trial NCT04486625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-08-10. Estimated completion is 2021-10-18.
What interventions are being tested in trial NCT04486625?
The interventions under investigation include: Aztreonam-Avibactam (DRUG).
Who is sponsoring clinical trial NCT04486625?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04486625's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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