Clinical trial NCT04840888: A Study of LY3484356 in Healthy Female Participants
Official title: Evaluation of the Effect of Food, Omeprazole, Itraconazole, and Carbamazepine on the Pharmacokinetics of LY3484356 in Healthy Females of Non-Child-Bearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356
timeFrame: Predose up to 168 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3484356
timeFrame: Predose up to 168 hours postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of LY3484356
timeFrame: Predose up to 168 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: