Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04486625 | Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment | PHASE1 | COMPLETED | 11 | — | — | Aug 10, 2020 | Oct 18, 2021 | Jul 28, 2023 | 1 | United States |
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 ...