A Study of LY3484356 in Healthy Female Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840888
• Other study ID #: 18204
• Secondary ID: J2J-MC-JZLD
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2021
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3484356
Administered orally.
• Omeprazole
Administered orally.
• Itraconazole
Administered orally.
• Carbamazepine
Administered orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3484356	PK: AUC[0-8] of LY3484356	Predose up to 168 hours postdose
Primary	PK: Maximum Observed Concentration (Cmax) of LY3484356	PK: Cmax of LY3484356	Predose up to 168 hours postdose
Primary	PK: Time of Maximum Observed Concentration (Tmax) of LY3484356	PK: Tmax of LY3484356	Predose up to 168 hours postdose