Clinical trial NCT02370485: A Study of LY2801653 in Healthy Participants Who Are Not Able to Have Children
Official title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653
timeFrame: 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
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653
timeFrame: 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:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652
timeFrame: 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
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652
timeFrame: 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
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: