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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY2801653

Study type: Interventional

Funder types: Industry

Identifiers

NCT02370485

I3O-EW-JSBD (Other Identifier)

15778

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 3 patient groups

LY2801653 Reference - Fasted

Experimental group

Description:

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

Treatment:

Drug: LY2801653

LY2801653 Test - Fasted

Experimental group

Description:

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

Treatment:

Drug: LY2801653

LY2801653 Test - Fed

Experimental group

Description:

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

Treatment:

Drug: LY2801653