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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07316608 | A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults | PHASE1 | ACTIVE NOT_RECRUITING | 44 | — | — | Mar 16, 2026 | May 29, 2026 | May 13, 2026 | 2 | United States |
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2).
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Treatment A | EXPERIMENTAL | Participants will receive a single oral Fixed Combination Drug Product (FCDP) test formulation 1 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment B | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment C | EXPERIMENTAL | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 1 rosuvastatin as Single Therapy Product (STP) reference formulations following an overnight fast. |
| Cohort 2 Treatment D | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment E | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment F | EXPERIMENTAL | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 2 rosuvastatin as STP reference formulations following an overnight fast. |
| Cohort 2 Treatment G | EXPERIMENTAL | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin in a fed state. |
| Name | Type | Description |
|---|---|---|
| Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 | DRUG | Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Laroprovstat Dose X STP | DRUG | Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Rosuvastatin Dose 1 STP | DRUG | Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
| Rosuvastatin Dose 2 STP | DRUG | Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures. * Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy tes...