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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03237988 | Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects | PHASE1 | COMPLETED | 24 | — | — | Jul 20, 2017 | Oct 4, 2017 | Jan 26, 2018 | 1 | United States |
Area under the plasma concentration-time curve (AUC) from time zero to infinity
AUC from time zero to the last quantifiable concentration
Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | ACTIVE_COMPARATOR | 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed). |
| Sequence BCA | ACTIVE_COMPARATOR | 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted). |
| Sequence CAB | ACTIVE_COMPARATOR | 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted). |
| Name | Type | Description |
|---|---|---|
| CPI-444 Capsules | DRUG | 100mg Capsule |
| CPI-444 Tablets | DRUG | 100mg Tablets |
Inclusion Criteria: 1. Males or females, of any race, 18 to 65 years of age, inclusive, at Screening. 2. Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening. 3. In good health. 4. Females will be nonpregnant and nonlactating, and females of childbearing potential and males will agr...