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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05767905 | A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants. | PHASE1 | COMPLETED | 18 | — | — | Mar 17, 2023 | Jun 20, 2023 | Jun 12, 2025 | 1 | United States |
The AUCinf was determined by AUClast + (Clast/kel), where Clast is 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 loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
The Cmax was observed directly from data.
| Arm | Type | Description |
|---|---|---|
| Part 1: PF-06821497 Sequence 1 | EXPERIMENTAL | Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C |
| Part 1: PF-06821497 Sequence 2 | EXPERIMENTAL | Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C |
| Part 2: PF-06821497 Sequence 1 | EXPERIMENTAL | Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment D * Drug: Single dose of PF-06821497 Treatment E * Drug: Single dose of PF-06821497 Treatment F |
| Name | Type | Description |
|---|---|---|
| PF-06821497 Treatment A | DRUG | A single dose of PF-06821497 administered under fasting conditions. |
| PF-06821497 Treatment B | DRUG | A single dose of PF-06821497 administered under fasting conditions. |
| PF-06821497 Treatment C | DRUG | A single dose of PF-06821497 administered under fasting conditions. |
| PF-06821497 Treatment D | DRUG | A single dose of PF-06821497 administered under fasting conditions. |
| PF-06821497 Treatment E | DRUG | A single dose of PF-06821497 administered after low fat meal |
| PF-06821497 Treatment F | DRUG | A single dose of PF-06821497 administered after high fat meal. |
Inclusion Criteria: * Participants ≥18 years of age, inclusive, at screening. * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. * BMI of ≥17.5 kg/m2; and a total...