Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06865571 administered Day 7-14 · 1 trial · 1 indication
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
| Arm | Type | Description |
|---|---|---|
| Effect of PF-05221304 on PF-06865571 PK | EXPERIMENTAL | - |
| Effect of PF-06865571 on PF-05221304 PK | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-06865571 administered Day 7-14 | DRUG | PF-06865571 administered Q12hr on Days 7-14 |
| PF-06865571 administered Day 1-14 | DRUG | PF-06865571 administered Q12hr on Day 7-14 |
| PF-05221304 administered Day 1-14 | DRUG | PF-05221304 administered Q12hr on Days 1-14 |
| PF-05221304 administered Day 7-14 | DRUG | PF-05221304 administered Q12hr Days 7-14 |
Inclusion criteria: 1. Healthy female subjects of nonchildbearing potential and/or male subjects. 2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Criteria 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonar...
PF-06865571 administered Day 7-14 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It was studied in a Phase 1 drug-drug interaction trial in healthy adult volunteers. The specific therapeutic indication has not been disclosed. The compound is not approved and remains in clinical development.
Pfizer, Inc. (ticker: PFE) is the developer of PF-06865571 administered Day 7-14. Pfizer sponsored the Phase 1 trial NCT03534648, which evaluated the pharmacokinetic drug-drug interaction between PF-05221304 and PF-06865571 in healthy adult subjects.
PF-06865571 administered Day 7-14 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT03534648, which enrolled 16 healthy adult volunteers in Belgium. The drug is investigational and has not been approved by the FDA or any regulatory agency.
PF-06865571 administered Day 7-14 has been studied in one completed Phase 1 trial, NCT03534648, titled Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects. The trial enrolled 16 healthy volunteers in Belgium and was controlled but not randomized or double-blind.
The therapeutic indication for PF-06865571 administered Day 7-14 has not been disclosed. The only completed trial, NCT03534648, was conducted in healthy adult volunteers to assess a pharmacokinetic drug-drug interaction with PF-05221304, not to evaluate efficacy in a specific disease.