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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04909853 | Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. | PHASE1 | COMPLETED | 35 | — | — | Jun 15, 2021 | Oct 7, 2021 | Aug 2, 2023 | 5 | United States |
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Total amount of unchanged drug excreted in the urine over 48 hours.
Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.
| Arm | Type | Description |
|---|---|---|
| PF-07321332 | EXPERIMENTAL | PF 07321332/ritonavir |
| Name | Type | Description |
|---|---|---|
| PF-07321332/ritonavir | DRUG | PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19 |
Inclusion Criteria: * Male or female, non-smoker and/or light smoker * Have a diagnosis of stable renal impairment * Meet the following estimated glomerular filtration rate (eGFR) criteria during the screening period (based on 2 Screening visits) based on the Chronic Kidney Disease Epidemiology Col...