A Study of LY2216684 in Subjects With Impaired Hepatic Function

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01241435
First received: November 12, 2010
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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 outpatient 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 mg LY2216684 given as 2 tablets.


Condition Intervention Phase
Depressive Disorder, Major
Drug: LY2216684
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Impaired Hepatic Function on the Pharmacokinetics of LY2216684

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics, area under the concentration curve (AUC) [ Time Frame: For up to 72 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: For up to 72 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time to maximum concentration (tmax) [ Time Frame: For up to 72 hours after administration of study drug ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684
Single oral dose of 18mg
Drug: LY2216684
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects: Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
  • Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or 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 mIU/mL).
  • Have a Body Mass Index (BMI) of 17.0 to 35.0 kg/m2, 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 are willing to follow study procedures.
  • Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site.

Control Subjects:

  • 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.

Subjects with Mild, Moderate, or Severe Hepatic Impairment:

  • Subjects with stable liver disease (alcoholic liver disease, posthepatitis, 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 subject, or of no additional clinical significance for this study.

Exclusion Criteria:

All subjects:

  • 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 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 that subjects 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 mL or more of blood in the 3 months prior to study entry.
  • Are subjects who have an average weekly alcohol intake that exceeds 21 units per week, or subjects unwilling to adhere to restrictions during the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  • Are subjects who are unwilling to adhere to study caffeine restrictions.
  • Are subjects 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 Subjects:

  • Have significant active hematological disease, history of significant active bleeding, or coagulation disorder.
  • Use or intended use of over-the-counter (including vitamins/mineral supplements, herbal medicine) or prescription medications 14 days, prior to enrollment and during the study.
  • Have history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
  • Evidence of hepatitis C and/or positive hepatitis C antibody.
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen.
  • Show evidence of significant active neuropsychiatric disease.

Subjects with Mild, Moderate, or Severe Hepatic Impairment:

  • Evidence of any significant active disease other than that responsible for or associated with liver impairment.
  • Have history or presence of cardiovascular, respiratory, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
  • Evidence of hepatorenal syndrome
  • Spontaneous bacterial peritonitis within 6 months of study entry.
  • Variceal bleeding within 3 months of study entry.
  • Severe hyponatremia (Na <120 mmol/L).
  • Presence of hepatocellular carcinoma.
  • Severe encephalopathy.
  • Hemoglobin <9.0 g/dL.
  • Platelet count <50 x 109 cells/L, values <50 x 109 cells/L may be permitted at the discretion of the investigator in consultation with the sponsor.
  • Concomitant use of any drug except those indicated for the treatment of liver disease or related complications.
  • Concomitant use of anticoagulants including warfarin.
  • Regular use of drugs of abuse and/or positive findings on urinary drug screening except those prescribed for related complications (ie, pain, insomnia, anxiety) of liver disease.
  • The use of medication known to interfere with hepatic metabolism (ie, barbiturates, phenothiazines) or known to alter other major organs or systems within 30 days prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241435

Locations
United States, Florida
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, United States, 33014
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, United States, 32809
United States, Texas
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, United States, 78215
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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01241435     History of Changes
Other Study ID Numbers: 12602, H9P-EW-LNCM
Study First Received: November 12, 2010
Last Updated: May 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014