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Drug interaction study: capivasertib meets rosuvastatin

NCT ID NCT07088913

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study looked at how the cancer drug capivasertib changes the way the body processes rosuvastatin, a common cholesterol-lowering medicine. Twenty healthy adults took rosuvastatin alone and then with capivasertib to compare drug levels in their blood. The results will help guide safe dosing when these drugs are used together.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
capivasertib and rosuvastatin
What this could lead to
If successful, this study could help doctors understand how to safely combine capivasertib with rosuvastatin or similar drugs.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only measures drug levels, not treatment effects or safety in real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Jul 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture. 2. Body Mass Index (BMI) between 18 and 32 kg/m² inclusive and weigh at least 50 kg and no more than 150 kg inclusive. 3. All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit and must not be lactating. 4. Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: 1. Postmenopausal (≥12 months of amenorrhea + hormone confirmation). 2. Irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy, and/or bilateral salpingectomy (excluding tubal ligation) at least 6 months prior to screening. 5. Male participants must be vasectomized (at least 6 months prior to screening), with documented post-procedural medical assessment of surgical success. 6. Participants must be willing to use study-specific contraceptive methods. Key Exclusion Criteria: 1. 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. 2. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. 3. Any clinically important illness, medical/surgical procedure, or trauma. 4. Any clinically significant skin abnormalities that are chronic or currently active. 5. Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results. 6. Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV antibody), or Human Immunodeficiency Virus (HIV). 7. Any clinically significant abnormalities in blood lipid profiles (triglycerides, high-density lipoprotein, low-density lipoprotein, and total cholesterol). 8. Any clinically significant abnormalities in glucose metabolism, including: 1. Diagnosis of type I or II diabetes mellitus (irrespective of management), 2. Fasting blood glucose ≥ 100 mg/dL, or 3. Hemoglobin A1c \> 5.7% after at least 8 hours of fasting at screening. 9. Any clinically significant abnormal findings in vital signs. 10. 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. 11. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months. 12. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. 13. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to capivasertib or rosuvastatin or history of hypersensitivity to any component of the finished dosage form of capivasertib. 14. Plasma donation or any blood donation/blood loss prior to the Screening Visit. 15. Participants who have previously received capivasertib.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Baltimore, Maryland, 21225, United States

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