Laroprovstat + Ezetimibe Bioavailability Study
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.
Are You a Good Fit for This Trial?
This trial is for healthy adults. People with certain health conditions, like high cholesterol or diabetic dyslipidemia, may be of interest in future studies, but only those without significant medical issues can join this phase.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single-dose treatments in a randomized, open-label, 4-period, cross-over design to assess the relative bioavailability of laroprovstat/ezetimibe fixed combination drug products versus single therapy products.
Washout
Washout periods between treatment phases to clear the drug from the body before the next treatment period begins.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares how the body absorbs and processes a combined tablet of laroprovstat and ezetimibe versus taking each drug separately. It also looks at whether eating affects how these drugs work. Participants receive all treatments at different times.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.