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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCV | Other Identifier | Eli Lilly and Company |
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This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc | Experimental | Period 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms [g/kg] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
|
| Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc | Experimental | Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
|
| LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 10 hours |
| 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. | Baseline, 10 hours |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684 | Predose through 24 hours postdose | |
| Pharmacokinetics: Observed Cmax of Alcohol | Predose through 24 hours postdose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 47710 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc | Period 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms [g/kg] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
| FG001 | Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc | Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
| FG002 | LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc | Period 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
| FG003 | Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc | Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Washout (7 Days) |
| |||||||||||||
| Period 2 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Baseline, 10 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2216684 + Placebo-matching Alcohol | 18 mg LY2216684 administered orally, once daily for 8 days. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C568831 | alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol |
| D000434 | Alcoholic Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
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| Experimental |
Period 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
|
| Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc | Experimental | Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. |
|
|
| Placebo-matching LY2216684 | Drug | Administered orally |
|
| Placebo-matching alcoholic beverage | Drug | Administered orally |
|
| Alcoholic beverage | Drug | Administered orally |
|
| Baseline, 10 hours |
| 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. | Baseline, 10 hours |
| 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 |
| 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 | 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. | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
| 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. | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
| 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. | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
| 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. | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time.
| OG001 | Placebo-matching LY2216684 + Alcohol | Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. |
| OG002 | LY2216684 + Placebo-matching Alcohol | 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. |
| OG003 | Placebo-matching LY2216684 + Placebo-matching Alcohol | Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. |
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 10 hours |
|
|
|
| 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. | Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable postural stability data. | Posted | Least Squares Mean | 95% Confidence Interval | 1/3 degree of angle of sway | Baseline, 10 hours |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 10 hours |
|
|
|
| Secondary | Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684 | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliters (ng/mL) | Predose through 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Observed Cmax of Alcohol | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | millimoles/liters (mmol/L) | Predose through 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684 | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data. | Posted | Median | Inter-Quartile Range | hours | Predose through 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Observed Tmax of Alcohol | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data. | Posted | Median | Inter-Quartile Range | hours | Predose through 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684 | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliters (ng*h/mL) | Predose through 24 hours postdose |
|
|
|
| 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 | Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | millimoles*hours/liters (mmol*h/L) | Predose through 12 hours postdose |
|
|
|
| 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. | Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable working memory data. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
|
|
|
| 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. | Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable episodic memory data. | Posted | Geometric Mean | 95% Confidence Interval | units on a scale | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | millisecond (msec) | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours |
|
|
|
| 0 |
| 27 |
| 16 |
| 27 |
| EG001 | Placebo-matching LY2216684 + Placebo-matching Alcohol | Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. | 0 | 27 | 8 | 27 |
| EG002 | LY2216684 + Alcohol | 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. | 0 | 27 | 10 | 27 |
| EG003 | Placebo-matching LY2216684 + Alcohol | Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. | 0 | 27 | 8 | 27 |
| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Burns first degree | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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Not provided
| Hour 2 |
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| Hour 3 |
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| Hour 4.5 |
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| Hour 6 |
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| Hour 8 |
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| Hour 10 |
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| Hour 2 |
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| Hour 3 |
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| Hour 4.5 |
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| Hour 6 |
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| Hour 8 |
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| Hour 10 |
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| Hour 2 |
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| Hour 3 |
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| Hour 4.5 |
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| Hour 6 |
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| Hour 8 |
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| Hour 10 |
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| Self-rated Alertness, Hour 2 |
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| Self-rated Alertness, Hour 3 |
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| Self-rated Alertness, Hour 4.5 |
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| Self-rated Alertness, Hour 6 |
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| Self-rated Alertness, Hour 8 |
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| Self-rated Alertness, Hour 10 |
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| Self-rated Contentment, Hour 1 |
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| Self-rated Contentment, Hour 2 |
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| Self-rated Contentment, Hour 3 |
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| Self-rated Contentment, Hour 4.5 |
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| Self-rated Contentment, Hour 6 |
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| Self-rated Contentment, Hour 8 |
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| Self-rated Contentment, Hour 10 |
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