Clinical trial NCT02818335: A Study of LY3023414 Formulations and the Effect of Food
Official title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.

The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.

This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.

This study is for research purposes only and is not intended to treat any medical conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria:

* Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
* Cannot be Lilly employees
* Have known allergies to LY3023414, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414
timeFrame: Pre-dose through 2 days post-dose in each period
measure: Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414
timeFrame: Pre-dose through 2 days post-dose in each period
measure: Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414
timeFrame: Pre-dose through 2 days post-dose in each period
measure: Pharmacokinetics (PK): Observed time of maximum concentration (tmax)
timeFrame: Pre-dose through 2 days post-dose in each period
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
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: