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). ...
A single dose of PF-07104091 as Formulation A is an investigational tablet version of PF-07104091, a small molecule developed by Pfizer, Inc. It was studied as a single oral dose in healthy adult male participants to evaluate how the tablet formulation behaves in the body. It is not an approved medicine.
PF-07104091 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the tablet formulation. The compound is an investigational small molecule and has not been approved for commercial use.
It is in Phase 1. The only clinical study of this tablet formulation, NCT05431153, was a Phase 1 trial that has been completed. The trial enrolled 30 healthy male participants in the United States. The drug remains investigational and is not approved for any use.
The trial was NCT05431153, titled A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants. It was a completed Phase 1 study with 30 enrolled healthy male volunteers aged 18 years and older, conducted in the United States. It used a controlled, randomized design without double blinding.
Yes. Single dose of PF-07104091 as Formulation A is also known as Single dose of PF-07104091 as Tablet Formulation A (Treatment A). Both names refer to the same tablet formulation of PF-07104091 given as a single dose in the Phase 1 study NCT05431153. Searches using either name point to the same investigational asset.
It is not used to treat any condition. The tablet formulation was given as a single dose to healthy adult male volunteers in a Phase 1 study, not to patients with a disease. No therapeutic indication has been disclosed for this formulation, and it is not approved for any medical use.