Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Palbociclib alone · 4 trials · 1 indication
Area under the concentration-time curve from time zero to infinity.
Maximum observed plasma concentration
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3 |
| Cohort 3 | EXPERIMENTAL | Cohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid. |
| Cohort 4 | EXPERIMENTAL | Cohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid. |
| Cohort 5 | EXPERIMENTAL | Cohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid. |
| Cohort 6 | EXPERIMENTAL | Cohort 6 will receive a 125 mg palbociclib oral solution |
| Fixed sequence modafinil DDI arm (Cohort 1) | EXPERIMENTAL | Fixed sequence study with treatment A of palbociclib alone, followed by treatment B of palbociclib with modafinil in Cohort 1. |
| Fixed sequence pioglitazone DDI arm (Cohort 2) | EXPERIMENTAL | For Cohort 2, fixed sequence study with treatment A of palbociclib alone, followed by treatment C of palbociclib with pioglitazone. |
| Fixed sequence | OTHER | Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole) |
| Fixed sequence crossover | EXPERIMENTAL | All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole. |
| Name | Type | Description |
|---|---|---|
| Palbociclib Alone | DRUG | In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. |
| Palbociclib + Rabeprazole | DRUG | In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. |
| Palbociclib plus Modafinil | DRUG | For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection. |
| Palbociclib plus pioglitazone | DRUG | For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection. |
| Palbociclib plus itraconazole | DRUG | Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection. |
Inclusion Criteria: * Healthy Male or Female of non-childbearing potential, * Having a body weight \>50 kg * Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2. Exclusion Criteria: * Any condition possibly affecting drug absorption (eg, gastrectomy) * A positive urine drug or cotinine tes...
Palbociclib alone is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is currently in Phase 1 clinical development. The drug is being evaluated in pharmacokinetic studies to understand how it interacts with other substances in the body.
Palbociclib alone is developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting Phase 1 clinical trials with this drug in healthy volunteers to study its pharmacokinetics and drug interactions.
Palbociclib alone is in Phase 1 clinical development. All four clinical trials for this drug are completed, with a total enrollment of 112 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Palbociclib alone has four completed Phase 1 trials: NCT01918176, NCT02131298, NCT02222441, and NCT02311946. These studies investigate drug interactions with proton pump inhibitors, itraconazole, modafinil, pioglitazone, and antacids, as well as bioavailability of experimental formulations.
Palbociclib alone refers to the drug studied in healthy volunteer trials, distinct from palbociclib used in cancer treatment. The trials listed focus on pharmacokinetics and drug interactions in healthy subjects, not on therapeutic efficacy in patients.