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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07622433 | A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults | PHASE1 | NOT YET_RECRUITING | 18 | — | — | Jun 10, 2026 | Sep 7, 2026 | Jun 4, 2026 | 1 | United States |
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. |
| Treatment B | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. |
| Treatment C | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. |
| Treatment D | EXPERIMENTAL | Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. |
| Name | Type | Description |
|---|---|---|
| Laroprovstat/ezetimibe FCDP | DRUG | Laroprovstat/ezetimibe will be administered orally. |
| Laroprovstat STP | DRUG | Laroprovstat will be administered orally. |
| Ezetimibe STP | DRUG | Ezetimibe will be administered orally. |
| Laroprovstat/ezetimibe FCDP-slow variant | DRUG | Laroprovstat/ezetimibe slow variant will be administered orally |
Inclusion Criteria: * Healthy male and female participants aged 18 to 55 years at the time of signing consent. * All females must have a negative pregnancy test at the Screening Visit and on admission to the study site. * Females of childbearing potential must not be lactating and if heterosexually...