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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

NCT07622433 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Laroprovstat/ezetimibe FCDP

Laroprovstat/ezetimibe will be administered orally.

DRUG

Laroprovstat STP

Laroprovstat will be administered orally.

DRUG

Ezetimibe STP

Ezetimibe will be administered orally.

DRUG

Laroprovstat/ezetimibe FCDP-slow variant

Laroprovstat/ezetimibe slow variant will be administered orally

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-09-07
Completion
2026-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622433 on ClinicalTrials.gov