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

Study identifier:D7963C00001

ClinicalTrials.gov identifier:NCT07622433

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Laroprovstat/ezetimibe FCDP, Laroprovstat STP, Ezetimibe STP, Laroprovstat/ezetimibe FCDP-slow variant

Sex

All

Estimated Enrollment

18

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 10 Jun 2026
Estimated Primary Completion Date: 07 Sept 2026
Estimated Study Completion Date: 07 Sept 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2026 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria