Healthy ParticipantsPhase 1NCT07088913
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants
A Phase 1 study testing Capivasertib and Rosuvastatin in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of the study is to assess the effect of capivasertib on the pharmacokinetics (PK) of oral rosuvastatin in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Capivasertib and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 20 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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.
- Plasma donation or any blood donation/blood loss prior to the Screening Visit.
- Participants who have previously received capivasertib.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- A Screening Period of maximum 28 days.
- 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.
- 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
- Being tested
- Capivasertib, Rosuvastatin
- Keywords
- Drug-drug interaction, Pharmacokinetics, Breast Cancer Resistance Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
Also called AZD5363
Capivasertib will be administered orally twice in Period 2.
RosuvastatinDrug
Also called CRESTOR
Rosuvastatin will be administered orally once in both Period 1 and Period 2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Capivasertib; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
To evaluate the PK (R AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of AUClast (R AUClast) of rosuvastatin
To evaluate the PK (R AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 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.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Terminal elimination half-life (t½λz) of rosuvastatin
To evaluate the PK (t½λz) of rosuvastatin when administered orally alone and in combination with capivasertib.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Terminal elimination rate constant (λz) of rosuvastatin
To evaluate the PK (λz) of rosuvastatin when administered orally alone and in combination with capivasertib.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
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.
Measured: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
AUClast of capivasertib
To evaluate the PK (AUClast) of capivasertib following oral dosing.
Measured: Period 2: Day 1 to Day 3
Concentration at the end of a dosing interval (Ctrough) of capivasertib
To evaluate the PK (Ctrough) of capivasertib following oral dosing.
Measured: Period 2: Day 1 to Day 3
Cmax of capivasertib
To evaluate the PK (Cmax) of capivasertib following oral dosing.
Measured: Period 2: Day 1 to Day 3
Number of participants with adverse events (AEs) and serious AEs
To assess the safety and tolerability of capivasertib when administered with rosuvastatin.
Measured: From Screening (Day -30 to Day -2) to follow-up visit (Day 10)
Change in serum bilirubin levels
To evaluate the effect of capivasertib dosing on total, conjugated, and unconjugated bilirubin levels.
Measured: Day 1 (pre-capivasertib dose) to Day 3 (post-capivasertib dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start28 Jul 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088913
- Sponsor's protocol ID
- D3615C00006
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07088913
- Acronym / sponsor ID
- D3615C00006
- Conditions
- Healthy Participants
- Keywords
- Drug-drug interaction, Pharmacokinetics, Breast Cancer Resistance Protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A Screening Period of maximum 28 days.
- 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.
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin/Capivasertib+Rosuvastatin | Experimental | Drug: Capivasertib, Drug: RosuvastatinParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Male participants must be vasectomized (at least 6 months prior to screening), with documented post-procedural medical assessment of surgical success.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapivasertibAlso: AZD5363Capivasertib will be administered orally twice in Period 2. | Drug | Rosuvastatin/Capivasertib+Rosuvastatin |
| RosuvastatinAlso: CRESTORRosuvastatin will be administered orally once in both Period 1 and Period 2. | Drug | Rosuvastatin/Capivasertib+Rosuvastatin |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
To evaluate the PK (AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
To evaluate the PK (AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.
Maximum observed drug concentration (Cmax) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
To evaluate the PK (Cmax) of rosuvastatin when administered orally alone and in combination with capivasertib.
11 secondary outcomes
Ratio of AUCinf (R AUCinf) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of AUClast (R AUClast) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of Cmax (R Cmax) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Terminal elimination half-life (t½λz) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Terminal elimination rate constant (λz) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Time to reach maximum observed concentration (tmax) of rosuvastatin
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
AUClast of capivasertib
Time frame: Period 2: Day 1 to Day 3
Concentration at the end of a dosing interval (Ctrough) of capivasertib
Time frame: Period 2: Day 1 to Day 3
Cmax of capivasertib
Time frame: Period 2: Day 1 to Day 3
Number of participants with adverse events (AEs) and serious AEs
Time frame: From Screening (Day -30 to Day -2) to follow-up visit (Day 10)
Change in serum bilirubin levels
Time frame: Day 1 (pre-capivasertib dose) to Day 3 (post-capivasertib dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capivasertib and Rosuvastatin in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin (time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.