RECRUITING

A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants

Conditions

Healthy Participants Drug-drug interaction Pharmacokinetics Breast Cancer Resistance Protein

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to assess the effect of capivasertib on the pharmacokinetics (PK) of oral rosuvastatin in healthy participants.

Official Title

An 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

Quick Facts

Study Start:2025-07-28

Study Completion:2025-09-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07088913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Baltimore, Maryland, 21225

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-28

Study Completion Date2025-09-29

Study Record Updates

Study Start Date2025-07-28

Study Completion Date2025-09-29

Terms related to this study

Keywords Provided by Researchers

Drug-drug interaction
Pharmacokinetics
Breast Cancer Resistance Protein

Additional Relevant MeSH Terms

Healthy Participants