A Study of the Effect of Abemaciclib on Metformin and Iohexol 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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-12-31

Brief Summary

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This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented.

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

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

SINGLE

Participants

Study Groups

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Placebo + Metformin

Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Abemaciclib + Metformin

Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Metformin

Intervention Type DRUG

Administered orally

Placebo + Iohexol

Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Group Type PLACEBO_COMPARATOR

Iohexol

Intervention Type DRUG

Administered intravenously (IV)

Placebo

Intervention Type DRUG

Administered orally

Abemaciclib + Iohexol

Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Iohexol

Intervention Type DRUG

Administered intravenously (IV)

Interventions

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Abemaciclib

Administered orally

Intervention Type DRUG

Metformin

Administered orally

Intervention Type DRUG

Iohexol

Administered intravenously (IV)

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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Inclusion Criteria

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria

* Have known allergies to abemaciclib, metformin, iodine, iohexol, 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 and/or positive antibodies of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes