A Study of Two Dosage Forms of LY2886721 in Healthy Participants - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: LY2886721 Capsule Drug: LY2886721 ODT	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 [ Time Frame: Baseline through 96 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of LY2886721 [ Time Frame: Baseline through 96 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 [ Time Frame: Baseline through 96 hours post-dose ] [ Designated as safety issue: No ]
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞] of LY2886721 [ Time Frame: Baseline through 96 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2013
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LY2886721 Capsule Reference formulation. A single oral dose of 70 mg LY2886721 in a capsule given with water and without a meal in one of four periods.	Drug: LY2886721 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 ODT Administered orally.
Experimental: LY2886721 - ODT (water, fasting) A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods.	Drug: LY2886721 ODT Administered orally.
Experimental: LY2886721 - ODT (water, fed) A single oral dose of a 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods.	Drug: LY2886721 ODT Administered orally.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775904

Locations

United States, Wisconsin
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, 53704

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01775904 History of Changes
Other Study ID Numbers:	14249, I4O-MC-BACG
Study First Received:	January 23, 2013
Last Updated:	May 23, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013