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palbociclib isethionate · 1 trial · 1 indication
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 |
|---|---|---|
| Palbociclib given to healthy volunteers | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib isethionate (phase 1 and 2 studies) | DRUG | 125 mg palbociclib isethionate salt under overnight fasting conditions |
| palbociclib commercial free base capsule | DRUG | 125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal) |
Inclusion Criteria: * Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Exclusion...
Palbociclib isethionate is a small molecule drug developed by Pfizer, Inc. (PFE). It is an investigational agent that has been studied in Phase 1 clinical development. The specific therapeutic indication for this isethionate form has not been disclosed.
Palbociclib isethionate targets CDK4, CDK6, and CCND1. It acts as an inhibitor of these proteins. CDK4 and CDK6 are cyclin-dependent kinases involved in cell cycle regulation, and CCND1 is cyclin D1.
Palbociclib isethionate is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this asset.
Palbociclib isethionate is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.
Palbociclib isethionate has been evaluated in one completed Phase 1 trial, NCT02041273, titled Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions. The trial enrolled 36 healthy volunteers in the United States and is no longer active.
Palbociclib isethionate is a salt form of palbociclib. The alternative name listed for this asset is palbociclib isethionate (phase 1 and 2 studies). It is distinct from other forms of palbociclib in how it is referenced in clinical study records.