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OpenTrials
Completed

NCT Number: NCT02370485

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

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2801653

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653

    Time frame: 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

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653

    Time frame: 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 outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652

    Time frame: 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

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2015
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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