A Study of Abemaciclib in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purposes of this study are to determine: * The effect of single increasing doses of the study drug, abemaciclib, on healthy participants. * The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given. * How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it. Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.

Key facts

Study ID

NCT02677844

Run by

Eli Lilly and Company

People needed

35

Starts

2016-02-01

Expected to finish

2016-07-01

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Overtly healthy males or females, as determined by medical history and physical examination
• Male participants will be sterile
• Female participants must not be of childbearing potential

You may not qualify if…

• Have known allergies to abemaciclib, related compounds, or any components of the formulation
• Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females)
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation
• Additional Exclusion Criterion for Participants Enrolled in Cohort 2:
• Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients

Where it is running

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

Full record on ClinicalTrials.gov

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