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

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ClinicalTrials.gov Identifier: NCT02370485
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY2801653 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects
Study Start Date : February 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: LY2801653 Reference - Fasted
Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.
Drug: LY2801653
Administered orally

Experimental: LY2801653 Test - Fasted
Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.
Drug: LY2801653
Administered orally

Experimental: LY2801653 Test - Fed
Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.
Drug: LY2801653
Administered orally




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370485


Locations
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United States, Florida
Covance
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02370485     History of Changes
Other Study ID Numbers: 15778
I3O-EW-JSBD ( Other Identifier: Eli Lilly and Company )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs