Clinical trial NCT01380691: A Study of LY2216684 in Healthy Participants
Official title: A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction of LY2216684 With Alcohol in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 28
Sex: ALL
Minimum age (years): 21
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 pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or female participants, as determined by medical history and physical examination
* Male participants: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
* Female participants: 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 due to menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone \[FSH\] \>40 milli-international units/milliliter \[mIU/mL\])
* Male and female participants: Examples of reliable methods of birth control include double-barrier methods (for example, condom and spermicide) alone or in combination with vasectomy, vasectomized partners, and abstinence.
* Have a body weight \>50 kilogram (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 (in sitting position) as determined by the investigator

Exclusion Criteria:

* Are currently enrolled in or 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 that are 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
* Participants 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
* 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 milliliter (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 ounces \[oz\] 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 are unwilling to adhere to study caffeine restrictions
* Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment or are unwilling to abstain during the study
* Have a documented or suspected history of glaucoma
* Participants with known or suspected alcohol dehydrogenase deficiency
* Participants who do not drink alcohol and/or are not willing to drink 4 units of alcohol over a 15-minute period
* Participants determined to be unsuitable by the investigator for any reason

Primary outcomes:
measure: Change From Baseline to 10 Hours in Power of Attention Composite Score
timeFrame: Baseline, 10 hours
measure: Change From Baseline to 10 Hours in Continuity of Attention Composite Score
timeFrame: Baseline, 10 hours
measure: Change From Baseline to 10 Hours in Postural Stability
timeFrame: Baseline, 10 hours
measure: Change From Baseline to 10 Hours in Self-Rated Alertness
timeFrame: Baseline, 10 hours
Secondary outcomes:
measure: Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
timeFrame: Predose through 24 hours postdose
measure: Pharmacokinetics: Observed Cmax of Alcohol
timeFrame: Predose through 24 hours postdose
measure: Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
timeFrame: Predose through 24 hours postdose
measure: Pharmacokinetics: Observed Tmax of Alcohol
timeFrame: Predose through 24 hours postdose
measure: Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
timeFrame: Predose through 24 hours postdose
measure: Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol
timeFrame: Predose through 12 hours postdose
measure: Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
timeFrame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
measure: Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
timeFrame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
measure: Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
timeFrame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
measure: Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
timeFrame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Other outcomes:
Locations:
city: Evansville
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: Indiana
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: