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A Study of LY2216684 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01380691
First received: June 22, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with Alcohol in Healthy Subjects. This study will run approximately for 34 days.


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2216684
Drug: LY2216684 Placebo
Drug: Alcohol Placebo containing beverage
Drug: Alcohol containing beverage
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction of LY2216684 With Alcohol in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in Power of Attention Composite Score [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Continuity of Attention Composite Score [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Postural Stability [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Self-Rated Alertness [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: maximum plasma concentration (Cmax) of LY2216684 and Alcohol [ Time Frame: Predose and up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: time to maximum plasma concentration (tmax) of LY2216684 and Alcohol [ Time Frame: Predose and up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the concentration-time curve over a dosing interval (AUCt) of LY2216684 [ Time Frame: Predose and up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the concentration-time curve from time zero to the last time point with a measurable concentration [AUC(0-tlast)] of Alcohol [ Time Frame: Predose and up to 12 hours post dose ] [ Designated as safety issue: No ]
  • Change in Working Memory [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Episodic Memory [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Speed of Retrieval of Information from Memory [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Change in Self-Ratings of Calmness and Contentment [ Time Frame: Predose, up to 10 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Period 1: 18 mg LY2216684 administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of alcohol containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally, one time. There will be a 7 day washout period between periods 1 and 2. Period 2: LY2216684 Placebo administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of alcohol containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally, one time.
Drug: LY2216684
Administered orally
Drug: LY2216684 Placebo
Administered orally
Drug: Alcohol Placebo containing beverage
Administered orally
Drug: Alcohol containing beverage
Administered orally
Experimental: Sequence 2
Period 1: LY2216684 Placebo administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of alcohol containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally, one time. There will be a 7 day washout period between periods 1 and 2. Period 2: 18 mg LY2216684 administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of alcohol containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally, one time.
Drug: LY2216684
Administered orally
Drug: LY2216684 Placebo
Administered orally
Drug: Alcohol Placebo containing beverage
Administered orally
Drug: Alcohol containing beverage
Administered orally
Experimental: Sequence 3
Period 1: 18 mg LY2216684 administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of alcohol containing beverage, to be taken orally, one time. There will be a 7 day washout period between periods 1 and 2. Period 2: LY2216684 Placebo administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of alcohol containing beverage, to be taken orally, one time.
Drug: LY2216684
Administered orally
Drug: LY2216684 Placebo
Administered orally
Drug: Alcohol Placebo containing beverage
Administered orally
Drug: Alcohol containing beverage
Administered orally
Experimental: Sequence 4
Period 1:LY2216684 Placebo administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of alcohol containing beverage, to be taken orally, one time. There will be a 7 day washout period between periods 1 and 2. Period 2: 18 mg LY2216684 administered orally once daily for 8 days. On day 6, participant will be administered 2 cups of Alcohol placebo containing beverage, to be taken orally one time. On day 8, participant will be administered 2 cups of alcohol containing beverage, to be taken orally, one time.
Drug: LY2216684
Administered orally
Drug: LY2216684 Placebo
Administered orally
Drug: Alcohol Placebo containing beverage
Administered orally
Drug: Alcohol containing beverage
Administered orally

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, 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 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 (hormonal methods of contraception, including oral and implantable contraceptives, are not allowed in this study); or Women who are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or are in menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mIU/mL).
  • Male and female subjects: Examples of reliable methods of birth control include: Double-barrier methods (eg, condom and spermicide) alone or in combination with vasectomy, vasectomized partners, and abstinence.
  • 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
  • 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 and pulse rate (sitting position) as determined by the investigator

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 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, related compounds or any components of the formulation
  • Are persons who have previously received the investigational product in this study or 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
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Subjects with a past history of alcohol dependence/abuse
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive 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 or during the study 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 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to each study period and while resident at the Clinical Research Unit(CRU) (except as required per this protocol); (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 of comparable caffeine content) per day, on a habitual basis, or any subjects unwilling to adhere to study caffeine restrictions
  • Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment or unwilling to abstain during the study
  • Have a documented or suspected history of glaucoma
  • Subjects with known or suspected alcohol dehydrogenase deficiency
  • Subjects who do not drink alcohol and/or are not willing to drink 4 units of alcohol over a 15-minute period
  • Subjects determined to be unsuitable by the investigator for any reason
  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: NCT01380691

Locations
United States, Indiana
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.
Evansville, Indiana, United States, 47710
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: NCT01380691     History of Changes
Other Study ID Numbers: 12613, H9P-EW-LNCV
Study First Received: June 22, 2011
Last Updated: September 16, 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
Ethanol
Phenylethyl Alcohol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Disinfectants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014