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A Study to Evaluate the Effect of Food on LY2216684

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01389765
First received: July 6, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Food on the Pharmacokinetics of LY2216684 in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) of LY2216684 [ Time Frame: Predose, up to 72 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum plasma concentration (Cmax) of LY2216684 [ Time Frame: Predose, up to 72 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: time to maximum plasma concentration (tmax) of LY2216684 [ Time Frame: Predose, up to 72 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684 administered in fasted then fed state
Period 1: 18 mg LY2216684 administered orally on Day 1, one time only, in fasted state. This will then be followed by a 7 day washout period prior to beginning the second period. Period 2: 18 mg LY2216684 administered orally on Day 1, one time only, in fed state.
Drug: LY2216684
Administered orally
Experimental: LY2216684 administered in fed then fasted state
Period 1: 18 mg LY2216684 administered orally on Day 1, one time only, in fed state. This will then be followed by a 7 day washout period prior to beginning the second period. Period 2: 18 mg LY2216684 administered orally on Day 1, one time only, in fasted state.
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 1 month 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 4 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, bilateral oophorectomy, or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mIU/mL)
  • All Subjects:

    • Are overtly healthy as determined by medical history and physical examination
    • Have a body weight >50 kg
    • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
    • Have venous access sufficient to allow for 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
    • Have normal blood pressure (BP) and pulse rate (sitting position)
    • Are willing to eat all components in the standard high-fat meal

Exclusion Criteria:

  • Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product 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, related compounds, or any components of the formulation
  • Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history of suicidal ideation or suicide attempts
  • Have a history of/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 C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Are women with a positive pregnancy test or women who are lactating
  • Intend to use over-the-counter or prescription medication within 14 days prior to dosing unless deemed acceptable by the investigator and sponsor's medical monitor, except for influenza vaccinations
  • Have donated blood of more than 500 mL within the last month
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to dosing in each period until discharge in each period (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)
  • Consume 5 or more cups of coffee (or other beverages or foods of comparable caffeine content) per day, on a habitual basis, or are unwilling to stop caffeine consumption from 48 hours prior to dosing in each period until discharge in each period
  • Subjects must adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU
  • Have consumed grapefruit or grapefruit-containing products, starfruit, or pomegranates 7 days prior to enrollment or are unwilling to avoid them during the study
  • Subjects determined to be unsuitable by the investigator for any reason
  • Have a documented or suspected history of glaucoma
  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: NCT01389765

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.
Daytona Beach, Florida, United States, 32117
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01389765     History of Changes
Other Study ID Numbers: 12620, H9P-EW-LNDC
Study First Received: July 6, 2011
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014