A Study of LY3484356 in Healthy Female Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the amount of LY3484356 that is found in the blood stream and how long the body takes to get rid of it when given with and without food. Participants are healthy females of non-childbearing potential. The study will also evaluate the tolerability and safety of LY3484356 by collecting the information about any side effects that may occur. The participant's involvement with the study will last approximately 27 days, not including screening.

Official Title
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Evaluation of the Effect of Food, Omeprazole, Itraconazole, and Carbamazepine on the Pharmacokinetics of LY3484356 in Healthy Females of Non-Child-Bearing Potential

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3484356
* Drug: Omeprazole
* Drug: Itraconazole
* Drug: Carbamazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical assessment Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²) Female participants of non childbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, bilateral tubal ligation, or bilateral tubal occlusion), or alternate medical cause/congenital anomaly (for example, Müllerian agenesis) or postmenopausal Exclusion Criteria: Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs Show evidence of hepatitis B, evidence of hepatitis C and/or have evidence of human immunodeficiency virus (HIV) infection Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing Use or intend to use medications that inhibit or induce CYP3A4 within 14 days prior to dosing until completion of the follow-up visit Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3484356 (Cohort 1)<br>LY3484356 administered as single doses orally with (fed) or without food (fasted). | Drug: LY3484356<br>* Administered orally.<br>|
| Experimental: LY3484356 + Omeprazole (Cohort 2)<br>LY3484356 administered as single dose orally on Day 1 and omeprazole administered orally as single dose on Days 5 to 8 followed by a single dose of LY3484356 co-administered with a single dose of omeprazole on Day 9 orally. | Drug: LY3484356<br>* Administered orally.<br>Drug: Omeprazole<br>* Administered orally.<br>|
| Experimental: LY3484356 + Itraconazole (Cohort 3)<br>LY3484356 administered as single dose orally on Day 1 and itraconazole administered orally as single dose on Days 5 to 9. The single dose of LY3484356 co-administered with a single dose of itraconazole on Day 10 orally followed by single dose of itraconazole administered orally on Days 11 to 16. | Drug: LY3484356<br>* Administered orally.<br>Drug: Itraconazole<br>* Administered orally.<br>|
| Experimental: LY3484356 + Carbamazepine (Cohort 4)<br>LY3484356 administered as single dose orally on Day 1 and carbamazepine administered orally as single dose on Days 5 to 11. The single dose of LY3484356 co-administered with a single dose of carbamazepine on Day 12 orally followed by single dose of carbamazepine administered orally on Days 13 to 15. | Drug: LY3484356<br>* Administered orally.<br>Drug: Carbamazepine<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 | PK: AUC[0-∞] of LY3484356 | Predose up to 168 hours postdose | 
| PK: Maximum Observed Concentration (Cmax) of LY3484356 | PK: Cmax of LY3484356 | Predose up to 168 hours postdose | 
| PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 | PK: Tmax of LY3484356 | Predose up to 168 hours postdose |