A Study of LY2801653 in Healthy Participants Who Are Not Able to Have Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. 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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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LY2801653 Reference - Fasted

Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.

Group Type EXPERIMENTAL

LY2801653

Intervention Type DRUG

Administered orally

LY2801653 Test - Fasted

Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.

Group Type EXPERIMENTAL

LY2801653

Intervention Type DRUG

Administered orally

LY2801653 Test - Fed

Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.

Group Type EXPERIMENTAL

LY2801653

Intervention Type DRUG

Administered orally

Interventions

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LY2801653

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy sterile male and female participants
* Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive
* Are willing and able to eat the protocol specified high-fat breakfast

Exclusion Criteria

* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have donated blood of more than 500 milliliter (mL) within the last month

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes