Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sequence 1: PCI-32765 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment A: PCI-32765 | EXPERIMENTAL | 420 mg capsules administered by mouth with 240 mL noncarbonated water 30 minutes after completing a high-fat breakfast |
| Treatment B: PCI-32765 | EXPERIMENTAL | 420 mg capsules administered by mouth with 240 mL noncarbonated water after fasting for at least 10 hours and 30 minutes before starting a high-fat breakfast |
| Treatment C: PCI-32765 | EXPERIMENTAL | 420 mg capsules administered by mouth with 240 mL noncarbonated water 2 hours after completing a high-fat breakfast |
| Treatment D: PCI-32765 | EXPERIMENTAL | 420 mg capsules administered with 240 mL noncarbonated water after fasting at least 10 hours |
| Treatment E: PCI-32765 | EXPERIMENTAL | 840 mg capsules administered with 240mL noncarbonated water 30 minutes after completing a high-fat breakfast |
| Name | Type | Description |
|---|---|---|
| Sequence 1: PCI-32765 | DRUG | Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B |
| Sequence 2: PCI-32765 | DRUG | Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C |
| Sequence 3: PCI-32765 | DRUG | Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D |
| Sequence 4: PCI-32765 | DRUG | Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A |
| Sequence 5: PCI-32765 | DRUG | After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK |
Inclusion Criteria: * Women must be postmenopausal or documented as surgically sterile * Men must agree to use an adequate contraception method as deemed appropriate by the investigator during the study and for 3 months after receiving the last dose of study drug, and to not donate sperm during the...
PCI-32765 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating the effect of food on its pharmacokinetics. The drug is not approved for any indication and remains in early-stage clinical research.
PCI-32765 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's properties, including a Phase 1 study in healthy volunteers. Johnson & Johnson is responsible for the drug's development and regulatory activities.
PCI-32765 is in Phase 1 clinical development. A Phase 1 study has been completed, which assessed the effect of food on the drug's pharmacokinetics in healthy volunteers. The drug is investigational and has not yet received regulatory approval for any use.
PCI-32765 has one completed clinical trial, NCT01820936, titled 'A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765.' This Phase 1 study enrolled 52 healthy volunteers in the United States and was a controlled, randomized trial.
PCI-32765 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers was designed to study how food affects the drug's pharmacokinetics, and further clinical development would be needed before any approval could be considered.