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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05349864 | A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults | PHASE1 | COMPLETED | 12 | — | — | Jun 17, 2022 | Sep 16, 2022 | Mar 15, 2024 | 1 | United States |
AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
| Arm | Type | Description |
|---|---|---|
| PF-07284890 Sequence 1 | EXPERIMENTAL | PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. |
| PF-07284890 Sequence 2 | EXPERIMENTAL | PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. |
| Name | Type | Description |
|---|---|---|
| PF-07284890 Treatment A | DRUG | PF-07284890 tablet by mouth while fasting |
| PF-07284890 Treatment B | DRUG | PF-07284890 tablet after low fat meal |
| PF-07284890 Treatment C | DRUG | PF-07284890 tablet after high fat meal |
Inclusion Criteria: * Females of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \...