A Study of LY2835219 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY2835219 Standard

Single oral dose of LY2835219 given with a standard meal in one of three study periods.

Group Type EXPERIMENTAL

LY2835219

Intervention Type DRUG

Administered orally.

LY2835219 Fasted

Single oral dose of LY2835219 given with no food in one of three periods.

Group Type EXPERIMENTAL

LY2835219

Intervention Type DRUG

Administered orally.

LY2835219 High-Fat

Single oral dose of LY2835219 given with a high fat meal in one of three periods.

Group Type EXPERIMENTAL

LY2835219

Intervention Type DRUG

Administered orally.

Interventions

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LY2835219

Administered orally.

Intervention Type DRUG

Other Intervention Names

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abemaciclib

Eligibility Criteria

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Inclusion Criteria

* Healthy sterile males or surgically sterile or postmenopausal females
* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening
* Are able to eat a high-fat, high-calorie meal

Exclusion Criteria

* Participated in a clinical trial involving investigational product within 30 days
* Abnormal blood pressure
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have donated blood of more than 500 milliliter (mL) within the last month
* Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes