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CompletedNCT07088913Updated Mar 3, 2026

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

A Phase 1 interventional study of Capivasertib and Rosuvastatin in Healthy Participants, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by AstraZeneca · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Healthy Participants

Keywords

  • Drug-drug interaction
  • Pharmacokinetics
  • Breast Cancer Resistance Protein
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Capivasertib · Drug: Rosuvastatin

Interventions

  • DrugCapivasertib

    Capivasertib will be administered orally twice in Period 2.

    Also known as: AZD5363

  • DrugRosuvastatin

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

    Also known as: CRESTOR

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Maximum observed drug concentration (Cmax) of rosuvastatin

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

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

Secondary outcomes

  1. Ratio of AUCinf (R AUCinf) of rosuvastatin

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

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

  2. Ratio of AUClast (R AUClast) of rosuvastatin

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

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

  3. Ratio of Cmax (R Cmax) of rosuvastatin

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

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

  4. Terminal elimination half-life (t½λz) of rosuvastatin

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

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

  5. Terminal elimination rate constant (λz) of rosuvastatin

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

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

  6. Time to reach maximum observed concentration (tmax) of rosuvastatin

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

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

  7. AUClast of capivasertib

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

    Time frame: Period 2: Day 1 to Day 3

  8. Concentration at the end of a dosing interval (Ctrough) of capivasertib

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

    Time frame: Period 2: Day 1 to Day 3

  9. Cmax of capivasertib

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

    Time frame: Period 2: Day 1 to Day 3

  10. Number of participants with adverse events (AEs) and serious AEs

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

    Time frame: From Screening (Day -30 to Day -2) to follow-up visit (Day 10)

  11. Change in serum bilirubin levels

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

    Time frame: Day 1 (pre-capivasertib dose) to Day 3 (post-capivasertib dose)

07

Study locations

1 site
  • Research Site
    Baltimore, Maryland 21225, United States
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07088913
Lead sponsor
AstraZeneca
Collaborators
Parexel
Responsible party
Sponsor
First posted
Jul 28, 2025
Start date
Jul 28, 2025
Primary completion
Feb 20, 2026
Completion
Feb 20, 2026
Last update
Mar 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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