A Study of LY3484356 in Healthy Female Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04840888
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 82
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LY3484356 (Cohort 1) LY3484356 LY3484356 administered as single doses orally with (fed) or without food (fasted). LY3484356 + Omeprazole (Cohort 2) LY3484356 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. LY3484356 + Itraconazole (Cohort 3) LY3484356 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. LY3484356 + Carbamazepine (Cohort 4) LY3484356 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. LY3484356 + Omeprazole (Cohort 2) Omeprazole 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. LY3484356 + Itraconazole (Cohort 3) Itraconazole 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. LY3484356 + Carbamazepine (Cohort 4) Carbamazepine 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.
- Primary Outcome Measures
Name Time Method PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 Predose up to 168 hours postdose PK: Tmax of LY3484356
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 Predose up to 168 hours postdose PK: AUC\[0-∞\] of LY3484356
PK: Maximum Observed Concentration (Cmax) of LY3484356 Predose up to 168 hours postdose PK: Cmax of LY3484356
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
LabCorp CRU, Inc.
🇺🇸Daytona Beach, Florida, United States
Covance Dallas
🇺🇸Dallas, Texas, United States