A Study of Two Dosage Forms of LY2886721 in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks. This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.

Key facts

Study ID: NCT01775904
Run by: Eli Lilly and Company
People needed: 26
Starts: 2013-02-01
Expected to finish: 2013-05-01
Last updated by the study team: 2019-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive, at screening
At least 4 participants who are greater than 55 years of age
Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product
Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone [FSH] level greater than 40 milli-international units per milliliter [mIU/mL])
Have venous access sufficient to allow for blood sampling as per the protocol

You may not qualify if…

Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 30 days, in a clinical trial involving an investigational product
Have known allergies to LY2886721, related compounds, or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a significantly abnormal blood pressure as determined by the investigator
Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody
Have a history of, or current, significant ophthalmologic disease
Show evidence of significant active neuropsychiatric disease or history of suicide attempt

Where it is running

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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