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Laroprovstat Dose X STP · 1 trial · 1 indication
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...
Laroprovstat Dose X STP is an investigational small molecule being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to compare the relative bioavailability of a fixed-dose combination of Laroprovstat and Rosuvastatin versus their single therapy products. The drug is not approved and remains in clinical development.
Laroprovstat Dose X STP is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy adult participants.
Laroprovstat Dose X STP is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied in healthy participants to assess its bioavailability.
Laroprovstat Dose X STP is associated with one completed Phase 1 clinical trial, identified as NCT07316608. This trial compared the relative bioavailability of a fixed-dose combination of Laroprovstat and Rosuvastatin versus their single therapy products in healthy adults. The study enrolled 44 participants in the United States.
Laroprovstat Dose X STP is a specific formulation or dose strength of the investigational drug Laroprovstat. It is being studied in combination with Rosuvastatin in a fixed-dose combination product. The Phase 1 trial compares this combination to the individual single therapy products.