Overview

A Study of LY3484356 in Healthy Female Participants

Status:
Recruiting
Trial end date:
2021-12-28
Target enrollment:
0
Participant gender:
Female
Summary
The main purpose of this study is to evaluate the amount of LY3484356 is found in the blood stream and how long the body takes to get rid of it when given with and without food, in healthy females participants 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 study will last approximately 27 days, not including screening.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Itraconazole
Omeprazole
Rifampin
Criteria
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