Este ensayo clínico tiene como objetivo estudiar cómo el medicamento capivasertib afecta la forma en que el cuerpo procesa otro medicamento, la rosuvastatina, en individuos sanos. La rosuvastatina se utiliza comúnmente para manejar los niveles de colesterol. Comprender la interacción entre estos dos medicamentos puede ayudar a determinar si el capivasertib cambia la absorción o la eficacia de la rosuvastatina, lo cual es crucial para garantizar planes de tratamiento seguros y efectivos cuando se usan ambos medicamentos juntos. Los participantes en el estudio primero pasarán por un proceso de selección para asegurarse de que sean aptos para el ensayo. En la primera fase, recibirán una dosis oral única de rosuvastatina. En la segunda fase, tomarán dos dosis de capivasertib, con un intervalo de 12 horas, siendo la primera dosis administrada junto con otra dosis de rosuvastatina. Hay un descanso de al menos 7 días entre las dos dosis de rosuvastatina para asegurar resultados precisos. Después de los tratamientos, se realiza una visita de seguimiento dentro de los 7 a 10 días para monitorear cualquier efecto y garantizar la seguridad del participante.
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.
está designado en este estudio
de ser asignado al grupo placebo