A Study of Abemaciclib in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected. This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part. This study is for research purposes only and is not intended to treat any medical condition.

Key facts

Study ID

NCT02672423

Run by

Eli Lilly and Company

People needed

127

Starts

2016-02-01

Expected to finish

2016-10-01

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy surgically sterile or postmenopausal females and sterile males
• Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

You may not qualify if…

• Have known allergies to abemaciclib, 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

Where it is running

• Daytona Beach Clinical Research Unit — Daytona Beach, Florida, United States
• Evansville Clinical Research Unit — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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