NCT06554821

A Study to Investigate the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin When Given in Healthy Participants

An Open-label, Randomised, Parallel-group, Fixed-sequence Study to Assess the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.

Detailed description

This study will be conducted at a single Clinical Unit. It includes 2 parallel arms (one for each rosuvastatin dose) and 2 treatment periods. The study will comprise: * A Screening Period of maximum 28 days. * Period 1: It will start on Day -1. A single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 1 followed by PK sampling of rosuvastatin for 96 hours. Participants will be admitted to the Clinical Unit on Study Day -1. Period 1 will end on Study Day 5. * Period 2: It will start on Study Day 6. A second single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 6 followed by PK sampling of rosuvastatin for 120 hours. Ticagrelor 90 mg, twice a day will be started on Day 6 (administered concomitantly with rosuvastatin) and administered through Day 10. Period 2 will end on Study Day 12. * A Follow-up Visit, 4 to 7 days after discharge.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2.
DRUG	Ticagrelor	Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10.

Timeline

• Start date: 2024-08-05
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2024-08-15
• Last updated: 2025-04-18

Locations

1 site across 1 country: Germany