A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants

Inclusion Criteria:

• Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
• Individuals 18 to 65 years of age at the time of screening.
• Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
• Female participants meet the following criteria.

Non-Childbearing Potential due to meeting at least one of the following criteria:

• Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
• Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.
• Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.

Exclusion Criteria:

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

• Participant has any clinically significant ECG abnormalities including the following:

  • Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement
  • QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.

• History of any clinically significant sensitivity or allergy to any medication or food.

• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.

• History or evidence of active tuberculosis (TB) disease or latent TB infection.