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
AstraZeneca
Summary
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.
Description
This is a randomized, open-label, 4-period, single-dose, cross-over study. The study will comprise of a screening period, 4 treatment periods, and 3 washout periods. The following treatments will be given during the study: * Treatment A: laroprovstat/ezetimibe fixed combination drug product (FCDP) test formulation in fasted state * Treatment B: laroprovstat tablet plus ezetimibe reference formulations in fasted state * Treatment C: laroprovstat/ezetimibe FCDP test formulation in fed state * Treatment D: laroprovstat/ezetimibe FCDP test formulation-slow variant in fasted state Participants w…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 active must agree to use an approved method of highly effective contraception. * Have a Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg. Exclusion Criteria: * History of any clinically important disease or disorder. * History or presence of gastrointestinal, hepat…
Interventions
- DrugLaroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
- DrugLaroprovstat STP
Laroprovstat will be administered orally.
- DrugEzetimibe STP
Ezetimibe will be administered orally.
- DrugLaroprovstat/ezetimibe FCDP-slow variant
Laroprovstat/ezetimibe slow variant will be administered orally
Location
- Research SiteBrooklyn, Maryland