Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aztreonam-Avibactam · 2 trials · 2 indications
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
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 |
|---|---|---|
| ATM-AVI treatment arm | EXPERIMENTAL | Chinese healthy volunteers |
| 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 Chinese male and female participants * No clinical relevant abnormalities * willing and able to comply with all study procedures * BMI:17.5-30.5 * Sign informed consent Exclusion Criteria: * Any clinical significant illness * History of alcohol abuse * Use within 14 ...
Aztreonam-Avibactam is an investigational small molecule being studied in healthy volunteers and in people with renal insufficiency. It is being developed by Pfizer, Inc. (PFE). As of now, it is in Phase 1 clinical development and has not been approved by the FDA.
Aztreonam-Avibactam is a combination of two antibiotics: aztreonam, which inhibits bacterial cell wall synthesis, and avibactam, which is a beta-lactamase inhibitor that protects aztreonam from degradation. This combination is designed to treat infections caused by certain resistant bacteria.
Aztreonam-Avibactam is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials.
Aztreonam-Avibactam is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one in the United States and one in China.
Aztreonam-Avibactam has completed two Phase 1 trials. NCT04486625 studied its pharmacokinetics in severe renal impairment in the United States, enrolling 11 participants. NCT04973826 assessed its pharmacokinetics, safety, and tolerability in healthy Chinese participants, enrolling 12 participants.
Aztreonam-Avibactam is a fixed-dose combination product containing two active ingredients: aztreonam and avibactam. It is not the same as avibactam alone, which is a beta-lactamase inhibitor used in other combination products. The combination is being studied for its potential to treat resistant bacterial infections.