Major Depressive Disorder
Conditions
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.
Interventions
DRUGLY2216684
Administered orally
DRUGPlacebo-matching LY2216684
Administered orally
DRUGPlacebo-matching alcoholic beverage
Administered orally
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 10 Hours in Power of Attention Composite Score | Baseline, 10 hours | Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Change From Baseline to 10 Hours in Continuity of Attention Composite Score | Baseline, 10 hours | Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Change From Baseline to 10 Hours in Postural Stability | Baseline, 10 hours | The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway. The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Change From Baseline to 10 Hours in Self-Rated Alertness | Baseline, 10 hours | Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684 | Predose through 24 hours postdose | — |
| Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol | Predose through 12 hours postdose | — |
| Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours | Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks known as the sensitivity index (SI). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. A series of 5 digits were presented on a computer screen, every second, for the participant to hold in memory. Followed by 30 probe digits, the participant had to decide whether it appeared in the original series by responding with 'Yes' or 'No'. This was repeated 2 times using different series and probes. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684 | Predose through 24 hours postdose | — |
| Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours | Speed of retrieval is a measure of complex information processing speed, summing reaction times from the two working memory (numeric and spatial) tasks and the two episodic recognition (word recognition and picture recognition) tasks. This composite score reflects the time it takes to decide correctly whether an item is held in working memory or episodic secondary memory.Scores are measured by response latencies, and smaller scores indicate better function. A negative change from baseline reflects impairment compared to baseline. LS means calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours | Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours | Episodic memory is based on how accurate the participant responds using the measures from immediate word recall (range 0-15), delayed word recall (range 0-15), word recognition (range 0-15), and picture recognition (range 0-20) tasks. The sum of four the accuracy scores, are summed, and averaged to provide a composite score (range 0-37.5). This composite score reflects the ability to store, hold, and retrieve information of an episodic nature (such as an event, a name, an object, a scene, or an appointment). A high score reflects someone able to recall memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect. |
| Pharmacokinetics: Observed Cmax of Alcohol | Predose through 24 hours postdose | — |
| Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684 | Predose through 24 hours postdose | — |
| Pharmacokinetics: Observed Tmax of Alcohol | Predose through 24 hours postdose | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants received 18 mg LY2216684 or Placebo-matching LY2216684 administered orally, once daily for 8 days during Periods 1 and 2. On Day 6 and on Day 8 of each period, participants were administered either 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men) or placebo-matching alcoholic beverage, taken orally, one time.
There was a 7-day washout period between Periods 1 and 2. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout (7 Days) | Protocol Violation | 0 | 0 | 0 | 1 |
| Washout (7 Days) | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 27 | 8 / 27 | 10 / 27 | 8 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Change From Baseline to 10 Hours in Continuity of Attention Composite Score
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable continuity of attention data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 10 Hours in Continuity of Attention Composite Score | -4.21 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 10 Hours in Continuity of Attention Composite Score | -1.16 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Continuity of Attention Composite Score | -3.31 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Continuity of Attention Composite Score | -1.24 units on a scale |
Primary
Change From Baseline to 10 Hours in Postural Stability
The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway. The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable postural stability data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 10 Hours in Postural Stability | 0.14 1/3 degree of angle of sway |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 10 Hours in Postural Stability | -3.51 1/3 degree of angle of sway |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Postural Stability | -3.65 1/3 degree of angle of sway |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Postural Stability | 5.2 1/3 degree of angle of sway |
Primary
Change From Baseline to 10 Hours in Power of Attention Composite Score
Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable power of attention data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 10 Hours in Power of Attention Composite Score | 67.82 minutes |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 10 Hours in Power of Attention Composite Score | 52.77 minutes |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Power of Attention Composite Score | 20.6 minutes |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Power of Attention Composite Score | 6.78 minutes |
Primary
Change From Baseline to 10 Hours in Self-Rated Alertness
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable self-rated alertness data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 10 Hours in Self-Rated Alertness | 3.85 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 10 Hours in Self-Rated Alertness | -2.37 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Self-Rated Alertness | 11.88 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 10 Hours in Self-Rated Alertness | 3.02 units on a scale |
Secondary
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
Episodic memory is based on how accurate the participant responds using the measures from immediate word recall (range 0-15), delayed word recall (range 0-15), word recognition (range 0-15), and picture recognition (range 0-20) tasks. The sum of four the accuracy scores, are summed, and averaged to provide a composite score (range 0-37.5). This composite score reflects the ability to store, hold, and retrieve information of an episodic nature (such as an event, a name, an object, a scene, or an appointment). A high score reflects someone able to recall memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable episodic memory data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 1 | -29.13 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 8 | -42.28 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 6 | -39.56 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 2 | -96.35 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 10 | -46.78 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 3 | -76.72 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 4.5 | -65.06 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 8 | -43.65 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 4.5 | -52.23 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 3 | -74.27 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 6 | -49.7 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 10 | -34.33 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 2 | -97.54 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 1 | -30.56 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 4.5 | -50.78 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 1 | -24.81 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 2 | -44.3 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 3 | -34.92 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 6 | -41.34 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 8 | -46.09 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 10 | -41.95 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 3 | -30.58 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 10 | -39.04 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 8 | -35.95 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 2 | -41.64 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 1 | -19.29 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 6 | -38.86 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory | Hour 4.5 | -34.29 units on a scale |
Secondary
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable calmness and contentment self-ratings.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 2 | 3.72 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 1 | 3.28 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 6 | 23.66 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 10 | 2.47 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 10 | 3.85 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 8 | 12.69 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 6 | 18.14 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 1 | 2.98 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 3 | 23.67 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 8 | 9.97 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 4.5 | 16.98 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 3 | 8.41 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 4.5 | 27.19 units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 2 | 17.09 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 4.5 | 8.5 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 1 | 4.57 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 2 | 14.08 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 3 | 26.25 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 4.5 | 20.74 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 6 | 17.25 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 8 | 3.63 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 10 | -2.37 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 1 | 0.95 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 2 | 1.5 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 3 | 7.12 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 6 | 10.85 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 8 | 0.98 units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 10 | 0.44 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 4.5 | 11.39 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 8 | 9.68 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 2 | 0.76 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 4.5 | 16.26 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 6 | 10.68 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 1 | 3.64 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 3 | 5.69 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 1 | 2.77 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 8 | 12.38 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 3 | 9.04 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 6 | 15.13 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 10 | 10.16 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 10 | 11.88 units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 2 | 1.64 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 10 | 3.02 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 1 | 4.34 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 8 | 2.7 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 2 | 2.79 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 3 | 1.22 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 3 | 1.32 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 2 | 3.64 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 4.5 | 5.03 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 10 | 3.72 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Contentment, Hour 6 | 4.57 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 6 | 7.55 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 1 | 6.06 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 8 | 3.03 units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment | Self-rated Alertness, Hour 4.5 | 9.82 units on a scale |
Secondary
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
Speed of retrieval is a measure of complex information processing speed, summing reaction times from the two working memory (numeric and spatial) tasks and the two episodic recognition (word recognition and picture recognition) tasks. This composite score reflects the time it takes to decide correctly whether an item is held in working memory or episodic secondary memory.Scores are measured by response latencies, and smaller scores indicate better function. A negative change from baseline reflects impairment compared to baseline. LS means calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable speed of retrieval of information from memory data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 1 | -38.46 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 8 | -116.72 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 6 | -116.69 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 2 | 104.48 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 10 | -74.78 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 3 | 43.69 millisecond (msec) |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 4.5 | 30.12 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 8 | -48.13 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 4.5 | 61.93 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 3 | 283.63 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 6 | 46.44 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 10 | -136.62 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 2 | 316.09 millisecond (msec) |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 1 | 36.22 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 4.5 | -121.55 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 1 | 42.51 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 2 | 59.65 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 3 | 51.53 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 6 | -90.46 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 8 | 55.62 millisecond (msec) |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 10 | -108.12 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 3 | 24.55 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 10 | -129.8 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 8 | -120.29 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 2 | 197.37 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 1 | 138.87 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 6 | -114.87 millisecond (msec) |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory | Hour 4.5 | 169.34 millisecond (msec) |
Secondary
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks known as the sensitivity index (SI). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. A series of 5 digits were presented on a computer screen, every second, for the participant to hold in memory. Followed by 30 probe digits, the participant had to decide whether it appeared in the original series by responding with 'Yes' or 'No'. This was repeated 2 times using different series and probes. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable working memory data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 1 | -0.12 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 8 | -0.03 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 6 | -0.1 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 2 | -0.27 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 10 | -0.21 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 3 | -0.2 Units on a scale |
| LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 4.5 | -0.15 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 8 | -0.05 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 4.5 | -0.11 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 3 | -0.18 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 6 | -0.09 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 10 | -0.09 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 2 | -0.29 Units on a scale |
| Placebo-matching LY2216684 + Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 1 | -0.12 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 4.5 | -0.2 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 1 | -0.1 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 2 | -0.13 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 3 | -0.06 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 6 | -0.06 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 8 | -0.08 Units on a scale |
| LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 10 | -0.16 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 3 | -0.04 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 10 | -0.06 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 8 | -0.13 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 2 | -0.12 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 1 | -0.02 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 6 | -0.07 Units on a scale |
| Placebo-matching LY2216684 + Placebo-matching Alcohol | Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory | Hour 4.5 | -0.2 Units on a scale |
Secondary
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 through 12 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol | 29.7 millimoles*hours/liters (mmol*h/L) | Geometric Coefficient of Variation 49 |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol | 34.5 millimoles*hours/liters (mmol*h/L) | Geometric Coefficient of Variation 43 |
Secondary
Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
Time frame: Predose through 24 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684 | 717 nanograms*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 41 |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684 | 678 nanograms*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 38 |
Secondary
Pharmacokinetics: Observed Cmax of Alcohol
Time frame: Predose through 24 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Observed Cmax of Alcohol | 11.4 millimoles/liters (mmol/L) | Geometric Coefficient of Variation 30 |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Observed Cmax of Alcohol | 13.8 millimoles/liters (mmol/L) | Geometric Coefficient of Variation 22 |
Secondary
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: Predose through 24 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684 | 60.2 nanograms/milliliters (ng/mL) | Geometric Coefficient of Variation 39 |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684 | 58.0 nanograms/milliliters (ng/mL) | Geometric Coefficient of Variation 36 |
Secondary
Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose through 24 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684 | 4.00 hours |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684 | 2.94 hours |
Secondary
Pharmacokinetics: Observed Tmax of Alcohol
Time frame: Predose through 24 hours postdose
Population: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LY2216684 + Alcohol | Pharmacokinetics: Observed Tmax of Alcohol | 0.92 hours |
| Placebo-matching LY2216684 + Alcohol | Pharmacokinetics: Observed Tmax of Alcohol | 0.92 hours |