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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01820936 | A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765 | PHASE1 | COMPLETED | 52 | — | — | Mar 1, 2013 | Jun 1, 2013 | Jul 15, 2014 | 1 | United States |
| 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...