Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single dose of PF-07104091 as Formulation A · 1 trial · 1 indication
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point 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.
Cmax was maximum observed concentration. Cmax was observed directly from data.
| Arm | Type | Description |
|---|---|---|
| PF-07104091 Sequence 1 | EXPERIMENTAL | Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
| PF-07104091 Sequence 2 | EXPERIMENTAL | Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
| PF-07104091 Sequence 3 | EXPERIMENTAL | Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
| PF-07104091 Sequence 4 | EXPERIMENTAL | Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
| PF-07104091 Sequence 5 | EXPERIMENTAL | Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
| PF-07104091 Sequence 6 | EXPERIMENTAL | Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
| Name | Type | Description |
|---|---|---|
| Single dose of PF-07104091 as Tablet Formulation A (Treatment A) | DRUG | A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions. |
| Single dose of PF-07104091 as Tablet Formulation B (Treatment B) | DRUG | A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions. |
| Single dose of PF-07104091 as Tablet Formulation C (Treatment C) | DRUG | A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions. |
| Single dose of PF-07104091 as Tablet Formulation D (Treatment D) | DRUG | A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions. |
| Single dose of PF-07104091 as Tablet Formulation C (Treatment E) | DRUG | A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions. |
Inclusion Criteria: * Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, 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 of \>50 kg (110 lb). ...