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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07215078 | Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants | PHASE1 | RECRUITING | 72 | — | — | Oct 8, 2025 | Jun 26, 2026 | Nov 28, 2025 | 1 | United States |
Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AB and BA will receive Dose A and Dose B atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 2 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AC and CA will receive Dose A and Dose C atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 3 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence BC and CB will receive Dose B and Dose C atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 4 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence AD and DA will receive Dose A and Dose D atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 5 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence BD and DB will receive Dose B and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Cohort 6 | EXPERIMENTAL | In Period 1 Day 1, participants from Sequence CD and DC will receive Dose C and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment. |
| Name | Type | Description |
|---|---|---|
| atirmociclib (PF-07220060) | DRUG | Open-label, two-period, cross-over study to evaluate dose proportionality of atirmociclib (PF-07220060) pharmacokinetics when administered under fed condition to healthy participants |
Inclusion: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. * Body mass Index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb.). Exclusion: * Evidence or history of clinically signif...