Recruiting

Capivasertib Impact on Rosuvastatin Pharmacokinetics in Healthy Participants

Study Aim

This study aims to assess how the drug Capivasertib affects the absorption and elimination of Rosuvastatin in healthy participants, during a Phase 1 trial.

What is being tested

Capivasertib

+ Rosuvastatin

Drug

Who is being recruted

From 18 to 60 Years

+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 1

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 28, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to study how the drug capivasertib affects the body's processing of another drug, rosuvastatin, in healthy individuals. Rosuvastatin is commonly used to manage cholesterol levels. Understanding the interaction between these two drugs can help in determining if capivasertib changes the absorption or effectiveness of rosuvastatin, which is crucial for ensuring safe and effective treatment plans when both drugs are used together. Participants in the study will first undergo a screening process to ensure they are suitable for the trial. In the first phase, they will receive a single oral dose of rosuvastatin. In the second phase, they will take two doses of capivasertib, 12 hours apart, with the first dose given alongside another dose of rosuvastatin. There's a break of at least 7 days between the two rosuvastatin doses to ensure accurate results. After the treatments, a follow-up visit occurs within 7 to 10 days to monitor any effects and ensure participant safety.

Official TitleAn Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin (a BCRP, OATP1B1 and OATP1B3 Sensitive Substrate) in Healthy Participants

NCT07088913

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 exclusion criteria prevent from participating

History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) and defined as Sick sinus syndrome, arrhythmia, prolonged QTcF > 450 ms, family history of long QT syndrome, persistent or intermittent bundle branch block, and atrio-ventricular block Grade II or III.

Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive a single dose of rosuvastatin in Period 1. After a minimum washout period of 7 days from the first dose of rosuvastatin, participants will receive the first dose of capivasertib, administered concomitantly with a single dose of rosuvastatin in Period 2, followed by a second dose of capivasertib after 12 hours.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Research Site

Baltimore, United StatesOpen Research Site in Google Maps

Recruiting

One Study Center