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

Part of paid clinical trials in Brooklyn, Maryland.

Sponsor
AstraZeneca
Study ID
NCT07622433
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Laroprovstat/ezetimibe FCDP — DRUG
    Laroprovstat/ezetimibe will be administered orally.
  • Laroprovstat STP — DRUG
    Laroprovstat will be administered orally.
  • Ezetimibe STP — DRUG
    Ezetimibe will be administered orally.
  • Laroprovstat/ezetimibe FCDP-slow variant — DRUG
    Laroprovstat/ezetimibe slow variant will be administered orally

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
May 2026
Primary completion
Sep 7, 2026
Completion
Sep 7, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Area under concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Research SiteBrooklynMaryland21225

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Research Site· Brooklyn, MD

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