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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY2801653

• Registration Number: NCT02370485
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-25
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2801653 Reference - Fasted	LY2801653	Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.
LY2801653 Test - Fasted	LY2801653	Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.
LY2801653 Test - Fed	LY2801653	Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653	Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653	Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652	Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652	Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

Trial Locations

Locations (1)

Covance; 🇺🇸 Daytona Beach, Florida, United States