Status:

COMPLETED

A Study of LY3484356 in Healthy Female Participants

Lead Sponsor:

Eli Lilly and Company

Conditions:

Healthy

Eligibility:

FEMALE

18-65 years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 26 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 12 2022

Estimated Enrollment :

82 Patients enrolled

Trial Details

Trial ID

NCT04840888

Start Date

April 26 2021

End Date

April 12 2022

Last Update

December 11 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

LabCorp CRU, Inc.

Daytona Beach, Florida, United States, 32117

2

Covance Dallas

Dallas, Texas, United States, 75247