A Study of Two Dosage Forms of LY2886721 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY2886721 in a Capsule; Drug: LY2886721 in an orally disintegrating tablet (ODT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775904

14249

I4O-MC-BACG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

LY2886721 Capsule (water, fasting)

Experimental group

Description:

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.

Treatment:

Drug: LY2886721 in a Capsule

LY2886721 ODT (no water, fasting)

Experimental group

Description:

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.

Treatment:

Drug: LY2886721 in an orally disintegrating tablet (ODT)

LY2886721 ODT (water, fed)

Experimental group

Description:

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.

Treatment:

Drug: LY2886721 in an orally disintegrating tablet (ODT)

LY2886721 ODT (water, fasting)

Experimental group

Description:

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.

Treatment:

Drug: LY2886721 in an orally disintegrating tablet (ODT)