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Capivasertib Impact on Rosuvastatin Pharmacokinetics in Healthy Participants

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Study AimThis 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

Healthy Participants

From 18 to 60 Years
+27 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: September 18, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 28, 2025Actual 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 
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: September 18, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Participants
Criteria
9 inclusion criteria required to participate
Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture
Body Mass Index (BMI) between 18 and 32 kg/m² inclusive and weigh at least 50 kg and no more than 150 kg inclusive
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit and must not be lactating
Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria

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18 exclusion criteria prevent from participating
History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study
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 important illness, medical/surgical procedure, or trauma
Any clinically significant skin abnormalities that are chronic or currently active

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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

To evaluate the PK (AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (Cmax) of rosuvastatin when administered orally alone and in combination with capivasertib.
Secondary Objectives

To evaluate the PK (R AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (R AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (R Cmax) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (t½λz) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (λz) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (tmax) of rosuvastatin when administered orally alone and in combination with capivasertib.

To evaluate the PK (AUClast) of capivasertib following oral dosing.

To evaluate the PK (Ctrough) of capivasertib following oral dosing.

To evaluate the PK (Cmax) of capivasertib following oral dosing.

To assess the safety and tolerability of capivasertib when administered with rosuvastatin.

To evaluate the effect of capivasertib dosing on total, conjugated, and unconjugated bilirubin levels.

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 SiteBaltimore, United StatesSee the location
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One Study Center