Study identifier:D7963C00001
ClinicalTrials.gov identifier:NCT07622433
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
Healthy Participants
Phase 1
Yes
Laroprovstat/ezetimibe FCDP, Laroprovstat STP, Ezetimibe STP, Laroprovstat/ezetimibe FCDP-slow variant
All
18
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2026 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. | Drug: Laroprovstat/ezetimibe FCDP Laroprovstat/ezetimibe will be administered orally. |
| Experimental: Treatment B Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. | Drug: Laroprovstat STP Laroprovstat will be administered orally. Drug: Ezetimibe STP Ezetimibe will be administered orally. |
| Experimental: Treatment C Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. | Drug: Laroprovstat/ezetimibe FCDP Laroprovstat/ezetimibe will be administered orally. |
| Experimental: Treatment D Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. | Drug: Laroprovstat/ezetimibe FCDP-slow variant Laroprovstat/ezetimibe slow variant will be administered orally |