Approval Probability
TA Base Rate
Adjusted LOA
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Also known as Laroprovstat
Laroprovstat/ezetimibe FCDP · 1 trial · 1 indication
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...
Laroprovstat/ezetimibe FCDP is an investigational fixed-combination drug product being studied for use in hypercholesterolaemia and in healthy participants. It combines laroprovstat with ezetimibe, and clinical development includes a Phase 1 bioavailability study in healthy adults.
Laroprovstat/ezetimibe FCDP is a small molecule combination product. Its components include laroprovstat and ezetimibe, and it is being evaluated for its effect on LDL-C in patients with hypercholesterolaemia.
Laroprovstat/ezetimibe FCDP is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials of this fixed-combination drug product in hypercholesterolaemia and in healthy participants.
Laroprovstat/ezetimibe FCDP is in Phase 1 clinical development. A Phase 1 crossover study is active but not recruiting participants, and it is not yet approved by regulatory authorities.
Laroprovstat/ezetimibe FCDP is involved in three trials. NCT07622433 is a Phase 1 bioavailability study in healthy adults. NCT07619118 and NCT07619131 are Phase 3 studies in hypercholesterolaemia, though they have not yet started recruiting.
Laroprovstat/ezetimibe FCDP is also known as laroprovstat/rosuvastatin 1 and Laroprovstat. It is a fixed-combination drug product that pairs laroprovstat with ezetimibe, and it is being studied alongside rosuvastatin in some trials.