A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults
Purpose
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.
Condition
- Healthy Participants
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts 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, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. - History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe. - Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit. - Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Each participant will be randomly assigned to one of the 3 treatment sequences: ABCD, BCAD or CABD.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment A |
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. |
|
|
Experimental Treatment B |
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. |
|
|
Experimental Treatment C |
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. |
|
|
Experimental Treatment D |
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. |
|
Recruiting Locations
Brooklyn, Maryland 21225
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed 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 will be randomly assigned to either of the 3 treatment sequences: ABCD, BCAD, or CABD.