Overview

This trial has been completed.

Condition healthy
Treatments ly3023414 reference fasted, ly3023414 test fasted, ly3023414 test fed
Phase phase 1
Sponsor Eli Lilly and Company
Start date July 2016
End date October 2016
Trial size 30 participants
Trial identifier NCT02818335, 15696, I6A-EW-CBBB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Single oral dose of LY3023414 (Reference) on day one fasting.
ly3023414 reference fasted
Administered Orally
(Experimental)
Single oral dose of LY3023414 (Test) on day one fasting.
ly3023414 test fasted
Administered Orally
(Experimental)
Single oral dose of LY3023414 (Test) on day one after a meal.
ly3023414 test fed
Administered Orally

Primary Outcomes

Measure
Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414
time frame: Pre-dose through 2 days post-dose in each period
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
time frame: Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414
time frame: Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Observed time of maximum concentration (tmax)
time frame: Pre-dose through 2 days post-dose in each period

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.