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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02653014 | Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment | PHASE1 | COMPLETED | 26 | — | — | Jul 29, 2015 | Mar 28, 2017 | Dec 16, 2025 | 1 | United States |
| NCT02228733 | Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074 | PHASE1 | COMPLETED | 46 | — | — | Jun 1, 2014 | Jan 1, 2015 | Dec 16, 2025 | - | — |
Rate of adverse events
Assessing the number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): pre dose and post dose
Assessing drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days |
| Cohort 2 | EXPERIMENTAL | Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days |
| Cohort 3 | EXPERIMENTAL | Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days |
| Cohort 4 | EXPERIMENTAL | Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days |
| KBP-5074: Cohort 1 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 2 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 3 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 4 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Cohort 5 | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| KBP-5074: Fed Group | EXPERIMENTAL | Healthy Volunteers will receive one dose of KBP-5074 |
| Name | Type | Description |
|---|---|---|
| KBP-5074 | DRUG | - |
Inclusion Criteria for Part 1: * Healthy male or female subject * Are between the ages of 18 and 45 years (inclusive); * Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg. Exclusion Criteria for Part 1: * Clinically significant history of gastrointestinal, card...