Een onderzoek naar LY4515100 bij gezonde deelnemers

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.

• Have a body mass index (BMI) within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive).

• Individuals not of childbearing potential (INOCBP) may participate in this trial.

• Participants in the Combined Oral Contraceptive Arm of Part C only:

  • must be 18 to 45 years of age (inclusive).
  • have a BMI within the range of 18.5 to 30 kg/m².
  • may be healthy pre-menopausal assigned female at birth (AFAB) individuals of child bearing potential (IOCBP).

Exclusion Criteria:

• Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.

• Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.

• Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.

• Participants with an estimated glomerular filtration rate less than (<) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m²).

• Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,

• increases the risks associated with participating in the study

• may confound ECG data analysis

• Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing.

• Smoke more than 10 cigarettes per day or the equivalent, including electronic cigarettes, and are unable to abide by investigative site smoking restrictions.

• Have an average weekly alcohol intake that exceeds 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable)

• Show evidence of

• Human immunodeficiency virus (HIV) infection and/or positive human HIV antigen and/or antibodies

• hepatitis C and/or positive hepatitis C antibody

• hepatitis B and/or positive hepatitis B surface antigen.

• Have liver disease.

• Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment.

• Part C Only:

  • Have history of neuropathy of any cause.
  • Have impaired hearing or a history of hearing problems.
  • Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other azoles.
  • Participants with any known history of thyroid disease

• Participants in the Combined Oral Contraceptive Arm of Part C only:

  • Are current smokers or have used nicotine, including tobacco or nicotine replacement products within 14 days prior to the first dose of combined oral contraceptive (COC), or plan to use nicotine, including tobacco or nicotine replacement products during the study.
  • Are at high risk for arterial or venous thrombotic diseases, autoimmune disease with lupus anticoagulants or anti-phospholipid syndrome, major surgery within the past 3 months, anticipated prolonged immobility.
  • Have abnormalities indicative of increased risk of VTE on the thrombophilia panel at screening.
  • Have undiagnosed abnormal uterine bleeding.
  • Have any history of breast, uterine or ovarian cancer.
  • Use of Vitamin C (greater than or equal to (≥) 500 mg/day) or acetaminophen within 14 days before dosing.
  • Have contraindications for the use of levonorgestrel/ethinyl estradiol.