Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aztreonam-Avibactam · 1 trial · 1 indication
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).
The Cmax of ATM was observed directly from data.
AUC0-24,ss of AVI 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 AVI 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).
The Cmax of AVI was observed directly from data.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Normal renal function |
| Cohort 2 | EXPERIMENTAL | Severe renal impairment (not on dialysis) |
| Name | Type | Description |
|---|---|---|
| Aztreonam-Avibactam | DRUG | 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 |
Inclusion Criteria: * Healthy female subjects and/or male subjects between the ages of 18 and 75 years, inclusive. Male and female subjects of childbearing potential must agree to use highly effective method(s) of contraception * Body mass index (BMI) of 17.5 to 40.5 kg/m2; and a total body weight ...
Aztreonam-Avibactam is an investigational small molecule drug combination developed by Pfizer, Inc. (NYSE: PFE). It is being studied in renal insufficiency, meaning it is evaluated in people whose kidney function is impaired. The program is in Phase 1 clinical development, with one completed pharmacokinetic trial conducted in the United States.
Aztreonam-Avibactam is being studied in renal insufficiency to assess how the drug combination behaves in people with impaired kidney function. The completed Phase 1 trial, NCT04486625, was a pharmacokinetic study in severe renal impairment. It enrolled 11 participants, including healthy volunteers, and was conducted in the United States.
Aztreonam-Avibactam is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this small molecule combination. The development work to date includes a single completed Phase 1 pharmacokinetic study in severe renal impairment.
Aztreonam-Avibactam is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed for the program. Because it remains in clinical development, it is investigational and has not been established as an approved therapy for renal insufficiency.
Aztreonam-Avibactam has been studied in one completed Phase 1 trial, NCT04486625, titled a pharmacokinetic study of Aztreonam-Avibactam in severe renal impairment. The trial enrolled 11 participants in the United States, included both sexes, and accepted participants aged 18 years and older, including healthy volunteers.
Yes. Aztreonam-Avibactam is also known as ATM-AVI, short for the combination of aztreonam and avibactam. These names refer to the same investigational small molecule combination developed by Pfizer, Inc. (PFE), which is in Phase 1 development for renal insufficiency.