A Study of Two Dosage Forms of LY2886721 in Healthy Participants

A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LY2886721 in a Capsule; Drug: LY2886721 in an orally disintegrating tablet (ODT)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2886721 Capsule (water, fasting); Reference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods.	Drug: LY2886721 in a Capsule; Administered orally.
Experimental: LY2886721 ODT (no water, fasting); A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods.	Drug: LY2886721 in an orally disintegrating tablet (ODT); Administered orally.
Experimental: LY2886721 ODT (water, fed); A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods.	Drug: LY2886721 in an orally disintegrating tablet (ODT); Administered orally.
Experimental: LY2886721 ODT (water, fasting); A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods.	Drug: LY2886721 in an orally disintegrating tablet (ODT); Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721	Baseline through 96 hours post-dose
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721	Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721	Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721	Baseline through 96 hours post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14249; I4O-MC-BACG (Other Identifier: Eli Lilly and Company)