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

NCT ID: NCT07088913

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2026-03-26

Brief Summary

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

Detailed Description

This study is an open-label, fixed-sequence, drug-drug interaction study of orally administered rosuvastatin in the presence and absence of capivasertib in healthy participants.

The study will comprise:

1. A Screening Period of maximum 28 days.

2. Two Treatment Periods

• Period 1: Participants will receive single oral dose of rosuvastatin.
• Period 2: Participants will receive two single oral doses of capivasertib administered 12 hours apart, with the first capivasertib dose being concomitantly administered with a single oral dose of rosuvastatin.

3. A final Follow-up Visit within 7 to 10 days after the last study intervention administration.

There will be a minimum washout period of at least 7 days between the first dose of rosuvastatin (in Treatment Period 1) and the second dose of rosuvastatin (in Treatment Period 2).

Conditions

Healthy Participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Rosuvastatin/Capivasertib+Rosuvastatin

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.

Group Type: EXPERIMENTAL

Capivasertib

Intervention Type: DRUG

Capivasertib will be administered orally twice in Period 2.

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin will be administered orally once in both Period 1 and Period 2.

Interventions

Capivasertib

Capivasertib will be administered orally twice in Period 2.

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin will be administered orally once in both Period 1 and Period 2.

Intervention Type: DRUG

Other Intervention Names

AZD5363; CRESTOR

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

AstraZeneca Clinical Study Information Center

Role: CONTACT

information.center@astrazeneca.com

1-877-240-9479

Other Identifiers

D3615C00006

Identifier Type: -

Identifier Source: org_study_id