Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as nirmatrelvir
Nirmatrelvir/ ritonavir · 2 trials · 2 indications
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated by linear/log trapezoidal method.
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir was observed directly from data.
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated by linear/log trapezoidal method.
Cmax was defined maximum observed concentration. Cmax for ritonavir was observed directly from data.
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method.
Cmax was defined as maximum plasma concentration. Cmax for nirmatrelvir was observed directly from data.
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for ritonavir was calculated by Linear/Log trapezoidal method.
Cmax was defined as maximum plasma concentration. Cmax for ritonavir was observed directly from data.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Nirmatrelvir/ritonavir | ACTIVE_COMPARATOR | Nirmatrelvir and ritonavir tablets |
| Treatment B: Nirmatrelvir/ ritonavir | EXPERIMENTAL | Nirmatrelvir/ritonavir with water |
| Treatment C: Nirmatrelvir/ ritonavir | EXPERIMENTAL | Nirmatrelvir/ ritonavir with infant formula |
| Treatment D: Nirmatrelvir/ ritonavir | EXPERIMENTAL | Nirmatrelvir/ ritonavir with vanilla pudding |
| Treatment E: Nirmatrelvir/ ritonavir | EXPERIMENTAL | Nirmatrelvir/ ritonavir with food and vanilla pudding |
| Name | Type | Description |
|---|---|---|
| Nirmatrelvir/ ritonavir | DRUG | Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition |
| Nirmatrelvir/Ritonavir | DRUG | Single oral dose of nirmatrelvir/ritonavir mixed in water under fasted condition |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Pa...
Nirmatrelvir/ritonavir is an investigational small molecule being studied for COVID-19, hepatic impairment, and bioavailability in healthy participants. It is developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development.
Nirmatrelvir/ritonavir is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is in Phase 1 clinical development for conditions including COVID-19 and hepatic impairment.
Nirmatrelvir/ritonavir is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing or completed to evaluate its safety and effects.
Nirmatrelvir/ritonavir has been studied in several Phase 1 trials, including NCT04962022, NCT04962230, NCT05064800, and NCT05441215. These trials assess drug-drug interactions and effects in healthy participants, including lactating women.
Yes, nirmatrelvir/ritonavir is also known as nirmatrelvir. The drug is a combination product that includes nirmatrelvir and ritonavir, and it is being developed by Pfizer, Inc. for COVID-19 and other conditions.