A Study of Abemaciclib in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

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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Abemaciclib Part A

Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.

Group Type EXPERIMENTAL

Abemaciclib Capsules (Reference Formulation)

Intervention Type DRUG

Administered orally

Abemaciclib Tablet (Test Formulation)

Intervention Type DRUG

Administered orally

Abemaciclib Part B

R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.

Group Type EXPERIMENTAL

Abemaciclib Capsules (Reference Formulation)

Intervention Type DRUG

Administered orally

Abemaciclib Tablet (Test Formulation)

Intervention Type DRUG

Administered orally

Abemaciclib Part C

T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.

Group Type EXPERIMENTAL

Abemaciclib Tablet (Test Formulation)

Intervention Type DRUG

Administered orally

Interventions

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Abemaciclib Capsules (Reference Formulation)

Administered orally

Intervention Type DRUG

Abemaciclib Tablet (Test Formulation)

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2835219 LY2835219

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes