Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as nirmatrelvir
PF-07321332/ritonavir · 5 trials · 3 indications
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method. Natural log-transformed AUClast for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUClast for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
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. Natural log-transformed AUCinf for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUCinf for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
Cmax for nirmatrelvir was observed directly from data. Natural log-transformed Cmax for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed Cmax for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
The Cmax of PF-07321332 in the study was observed directly from data.
The AUCtau of PF-07321332 was determined by Linear/Log trapezoidal method.
Cmax was defined as maximum observed plasma concentration and can be observed directly from data.
AUCinf was defined as area under the concentration-time curve from time 0 to infinity and was calculated as AUClast + (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
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 |
|---|---|---|
| Treatment A: PF-07321332/ritonavir | ACTIVE_COMPARATOR | PF-07321332 ritonavir |
| Treatment B: PF-07321332/ritonavir | EXPERIMENTAL | PF-07321332/ritonavir mixed with water |
| Treatment C: PF-07321332/ritonavir | EXPERIMENTAL | PF-07321332/ritonavir mixed with applesauce |
| Treatment D: PF-07321332/ritonavir | EXPERIMENTAL | PF-07321332/ritonavir mixed with vanilla pudding |
| Treatment A: PF-0732133/ritonavir | ACTIVE_COMPARATOR | PF-07321332 ritonavir |
| Treatment E: PF-07321332 | EXPERIMENTAL | PF-07321332 |
| Period 1 | EXPERIMENTAL | PF-07321332/ritonavir orally |
| Period 2 | EXPERIMENTAL | Itraconazole + PF-07321332/ritonavir orally. |
| PF-07321332 | EXPERIMENTAL | PF 07321332/ritonavir |
| Name | Type | Description |
|---|---|---|
| PF-07321332/ritonavir | DRUG | Single oral dose of PF-07321332/ritonavir under fasted conditions |
| PF-07321332 | DRUG | PF-07321332 will be administered as single oral dose orally. |
| Itraconazole | DRUG | Administered orally once daily for 8 days from Days 1 through 8 |
| Carbamazepine | DRUG | In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15. |
| PF 07321332/ritonavir | DRUG | In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally. |
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.