Trials / Completed
CompletedNCT04486625
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
AN OPEN-LABEL, PARALLEL-GROUP, PHARMACOKINETIC STUDY OF MULTIPLE INTRAVENOUS DOSES OF AZTREONAM AND AVIBACTAM IN SUBJECTS WITH SEVERE RENAL IMPAIRMENT AND NORMAL RENAL FUNCTION
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aztreonam-Avibactam | 500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours |
| DRUG | Aztreonam-Avibactam | 675/225 mg ATM/AVI loading infusion, followed by 675/225 mg ATM/AVI extended loading infusion, then 675/225 mg ATM/AVI maintenance dose infusion every 8 hours |
Timeline
- Start date
- 2020-08-10
- Primary completion
- 2021-09-20
- Completion
- 2021-10-18
- First posted
- 2020-07-24
- Last updated
- 2023-07-28
- Results posted
- 2023-07-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04486625. Inclusion in this directory is not an endorsement.