A Study of LY2216684 in Participants With Impaired Hepatic Function

NCT01241435 | Completed Phase 1 Results

• 2 other identifiers: 12602H9P-EW-LNCM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study. The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Area Under the Concentration Curve (AUC)

  The area under the plasma concentration versus time curve from 0 hours to infinity (AUC \[0-∞\]) for LY2216684 is presented.

  Up to 72 hours after administration of study drug

• Pharmacokinetics: Maximum Concentration (Cmax)

  Up to 72 hours after administration of study drug

• Pharmacokinetics: Time to Maximum Concentration (Tmax)

  Up to 72 hours after administration of study drug

Study Arms (1)

LY2216684

EXPERIMENTAL

LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C)

Drug: LY2216684

Interventions

LY2216684 DRUG

Administered orally

Also known as: Edivoxetine

LY2216684

Eligibility Criteria

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

You may qualify if:

• Male participants: Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
• Female participants: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, who have used a reliable method of birth control for 6 weeks prior to administration of study drug, and who agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug or are women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and follicle stimulating hormone \[FSH\] levels greater than or equal to 40 milli-internation units per milliliter \[mIU/mL\]).
• Have a body mass index (BMI) of 17.0 to 35.0 kilograms per meters squared (kg/m\^2), inclusive, at screening.
• Have acceptable blood pressure and pulse rate (sitting) as determined by the investigator.
• Have venous access sufficient to allow blood sampling as per the protocol.
• Are reliable and willing to make themselves available for the duration of the study and to follow study procedures.
• Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site.
• Control Participants (Participants with Normal Hepatic Function):
• Are overtly healthy, as determined by medical history and physical examination.
• Have clinical laboratory test results within normal reference ranges for the investigative site or results with acceptable deviations, which are judged to be not clinically significant by the investigator, at the time of screening.
• Participants with Mild, Moderate, or Severe Hepatic Impairment:
• Participants with stable liver disease (alcoholic liver disease, post-hepatitis, biliary cirrhosis, cryptogenic) classified as Child-Pugh score A, B, or C (Pugh et al. 1973).
• Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant or of no additional clinical significance for this study.

You may not qualify if:

• All Participants:
• Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug used in this study or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have known allergies to LY2216684 or related compounds.
• Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 in the past 6 months from screening.
• Have an electrocardiogram (ECG) reading considered clinically significant by the investigator or a history of significant cardiac dysrhythmia or conduction defect that, in the opinion of the investigator, increases the risks associated with participating in the study.
• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
• There is evidence or history of neurological disease such as transient ischemic attack, stroke, syncope episodes, encephalitis, or meningitis, except participants with liver disease-related encephalopathy may be allowed.
• Presence of acute infection with fever.
• Are women with a positive pregnancy test or women who are lactating.
• Have lost 500 milliliters (mL) or more of blood in the 3 months prior to study entry.
• Are participants who have an average weekly alcohol intake that exceeds 21 units per week, or are unwilling to adhere to restrictions during the study (1 unit = 12 ounces \[oz\] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits).
• Are participants who are unwilling to adhere to study caffeine restrictions.
• Are participants who are unwilling to abide by smoking restrictions while resident in the clinical research unit (CRU).
• Have a documented or suspected history of glaucoma.
• Control Participants (Participants with Normal Hepatic Function):

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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.

Miami, Florida, 33014, United States

Location

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.

Orlando, Florida, 32809, United States

Location

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.

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-03

Locations

US (3)