NCT05787002

A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.

An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.

Detailed description

Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state: Treatment A: single dose of rosuvastatin tablet alone Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet The study will comprise: 1. A Screening Period of maximum 28 days. 2. Two Treatment Periods up to 3 days 3. A follow-up period of 10 to 12 days after the last administration of the study drug. Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3). The total duration of the study will be up to 9 weeks.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	AZD0780	AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
DRUG	Rosuvastatin	Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2023-03-28
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study