A Study of Two Dosage Forms of LY2886721 in Healthy Participants

NCT01775904 | Completed Phase 1 Results

• 2 other identifiers: 14249I4O-MC-BACG
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

LY2886721 Capsule (water, fasting)

EXPERIMENTAL

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

LY2886721 ODT (no water, fasting)

EXPERIMENTAL

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)

LY2886721 ODT (water, fed)

EXPERIMENTAL

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)

LY2886721 ODT (water, fasting)

EXPERIMENTAL

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)

Interventions

LY2886721 in a Capsule DRUG

Administered orally.

LY2886721 Capsule (water, fasting)

LY2886721 in an orally disintegrating tablet (ODT) DRUG

Administered orally.

LY2886721 ODT (no water, fasting); LY2886721 ODT (water, fasting); LY2886721 ODT (water, fed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 53704, United States

Location

MeSH Terms

Interventions

N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

US (1)