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

AstraZeneca

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Capivasertib; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07088913

D3615C00006

Details and patient eligibility

About

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

Full 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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Rosuvastatin/Capivasertib+Rosuvastatin

Experimental group

Description:

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.

Treatment:

Drug: Rosuvastatin

Drug: Capivasertib