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

NCT07088913 | Completed Phase 1 FDA Drug

• 1 other identifier: D3615C00006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Drug-drug interaction; Pharmacokinetics; Breast Cancer Resistance Protein

Outcome Measures

Primary Outcomes (3)

• Area under concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin

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

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of rosuvastatin

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

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Maximum observed drug concentration (Cmax) of rosuvastatin

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

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

Secondary Outcomes (11)

• Ratio of AUCinf (R AUCinf) of rosuvastatin

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Ratio of AUClast (R AUClast) of rosuvastatin

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Ratio of Cmax (R Cmax) of rosuvastatin

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Terminal elimination half-life (t½λz) of rosuvastatin

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

• Terminal elimination rate constant (λz) of rosuvastatin

  Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3

Study Arms (1)

Rosuvastatin/Capivasertib+Rosuvastatin

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.

Drug: Capivasertib; Drug: Rosuvastatin

Interventions

Capivasertib DRUG

Capivasertib will be administered orally twice in Period 2.

Also known as: AZD5363

Rosuvastatin/Capivasertib+Rosuvastatin

Rosuvastatin DRUG

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

Also known as: CRESTOR

Rosuvastatin/Capivasertib+Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Postmenopausal (≥12 months of amenorrhea + hormone confirmation).
• Irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy, and/or bilateral salpingectomy (excluding tubal ligation) at least 6 months prior to screening.
• Male participants must be vasectomized (at least 6 months prior to screening), with documented post-procedural medical assessment of surgical success.
• Participants must be willing to use study-specific contraceptive methods.

You may not qualify if:

• 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.
• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
• 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).
• Any clinically significant abnormalities in blood lipid profiles (triglycerides, high-density lipoprotein, low-density lipoprotein, and total cholesterol).
• Any clinically significant abnormalities in glucose metabolism, including:
• Diagnosis of type I or II diabetes mellitus (irrespective of management),
• Fasting blood glucose ≥ 100 mg/dL, or
• Hemoglobin A1c \> 5.7% after at least 8 hours of fasting at screening.
• Any clinically significant abnormal findings in vital signs.
• 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.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

capivasertib; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 28, 2025
• Study Start: July 28, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)