Clinical trial NCT01389765: A Study to Evaluate the Effect of Food on LY2216684
Official title: Effect of Food on the Pharmacokinetics of LY2216684 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 \[at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) \>40 mIU/mL (milli-international-units/milliliter)\]
* All Subjects:

  * Are overtly healthy as determined by medical history and physical examination
  * Have a body weight \>50 kg (kilogram)
  * 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 (milliliter) 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 \[1 unit = 12 oz (ounces) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits\]
* 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

Primary outcomes:
measure: Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
measure: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
measure: Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: 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.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: