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

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Research Site
Brooklyn, Maryland 21225

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
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.