A Study of Two Dosage Forms of LY2886721 in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775904
• Other study ID #: 14249
• Secondary ID: I4O-MC-BACG
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: May 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2886721 in a Capsule
Administered orally.
• LY2886721 in an orally disintegrating tablet (ODT)
Administered orally.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721		Baseline through 96 hours post-dose
Primary	Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721		Baseline through 96 hours post-dose
Primary	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
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8] of LY2886721		Baseline through 96 hours post-dose