NCT07316608

A Phase I, Open-label, Crossover Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults

A Phase I, Randomized, Open-label, 3 or 4-period, 7-treatment, Single-dose, Two Cohort, Crossover Study to Assess the Relative Bioavailability of Laroprovstat/Rosuvastatin Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.

Detailed description

This is a randomized, open-label, 3 or 4-period, single-dose, two-cohort, multi-center, crossover study. The study will comprise of a screening period (21 Days), 3 or 4 treatment periods (depending on cohort assignment) and washout period (14 Days, starting after dosing on Study Day 1 of a given treatment period). Each treatment period consists of dosing on Day 1; any subsequent treatment period will not start sooner than 14 days following dosing in the previous treatment period.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1	Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1	Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2	Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2	Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Laroprovstat Dose X STP	Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Rosuvastatin Dose 1 STP	Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
DRUG	Rosuvastatin Dose 2 STP	Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-05-29
• Completion: 2026-05-29
• First posted: 2026-01-05
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study