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Trial record 12 of 27 for:    Edivoxetine OR LY2216684

A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01389752
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : October 19, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 6, 2011
First Posted Date  ICMJE July 8, 2011
Results First Submitted Date  ICMJE February 17, 2018
Results First Posted Date  ICMJE October 19, 2018
Last Update Posted Date January 4, 2019
Study Start Date  ICMJE July 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
    The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
  • Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
    The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
  • Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
    The tmax for LY2216684 was assessed.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
  • Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
  • Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
  • Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684 [ Time Frame: Predose, up to 72 hours after administration of study drug ]
Change History Complete list of historical versions of study NCT01389752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects
Official Title  ICMJE Effect of Activated Charcoal on the Pharmacokinetics of LY2216684 in Healthy Subjects
Brief Summary

The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal.

The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: LY2216684
    Administered orally
  • Drug: Activated Charcoal
    Administered orally
Study Arms  ICMJE
  • Experimental: LY2216684 without Charcoal, then with Charcoal
    Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days.
    Interventions:
    • Drug: LY2216684
    • Drug: Activated Charcoal
  • Experimental: LY2216684 with Charcoal, then without Charcoal
    Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days.
    Interventions:
    • Drug: LY2216684
    • Drug: Activated Charcoal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2011)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are overtly healthy, as determined by medical history and physical examination

    - Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of the 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 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 a follicle stimulating hormone [FSH] >40 mIU/mL [milli-international-units/milliliter])

  • 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)

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 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
  • Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation
  • Have a documented or suspected history of glaucoma
  • 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 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. Exceptions include influenza vaccinations, the use of topical medication (provided there is no evidence of chronic dosing with the risk of systemic exposure), occasional use of acetaminophen/paracetamol/ibuprofen, hormone replacement therapy including thyroid replacement (stable dose for at least 1 month), and stable doses (at least 1 month) of oral contraceptive therapy
  • 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 unwilling to adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU.
  • Have consumed grapefruit or grapefruit-containing products 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01389752
Other Study ID Numbers  ICMJE 12612
H9P-EW-LNCU ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP