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Trial record 17 of 27 for:    Edivoxetine OR LY2216684

A Study of LY2216684 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01380691
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: LY2216684
Drug: Placebo-matching LY2216684
Drug: Placebo-matching alcoholic beverage
Drug: Alcoholic beverage
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Period 1
Started 7 7 7 7
Completed 7 7 7 7
Not Completed 0 0 0 0
Period Title: Washout (7 Days)
Started 7 7 7 7
Completed 7 7 6 6
Not Completed 0 0 1 1
Reason Not Completed
Protocol Violation             0             0             0             1
Withdrawal by Subject             0             0             1             0
Period Title: Period 2
Started 7 7 6 6
Completed 7 7 6 6
Not Completed 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
37.3  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
10
  35.7%
Male
18
  64.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
White
19
  67.9%
Black or African American
8
  28.6%
Multiple
1
   3.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
 100.0%
1.Primary Outcome
Title Change From Baseline to 10 Hours in Power of Attention Composite Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
67.82
(22.01 to 113.63)
52.77
(7.05 to 98.5)
20.6
(-25.13 to 66.33)
6.78
(-39.13 to 52.69)
2.Primary Outcome
Title Change From Baseline to 10 Hours in Continuity of Attention Composite Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.21
(-6.98 to -1.43)
-1.16
(-3.93 to 1.61)
-3.31
(-6.08 to -0.54)
-1.24
(-4 to 1.53)
3.Primary Outcome
Title Change From Baseline to 10 Hours in Postural Stability
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: 1/3 degree of angle of sway
0.14
(-5.38 to 5.66)
-3.51
(-9.03 to 2)
-3.65
(-9.17 to 1.87)
5.2
(-0.32 to 10.72)
4.Primary Outcome
Title Change From Baseline to 10 Hours in Self-Rated Alertness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.85
(-4.25 to 11.95)
-2.37
(-10.47 to 5.72)
11.88
(3.77 to 19.98)
3.02
(-5.1 to 11.14)
5.Secondary Outcome
Title Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
Hide Description [Not Specified]
Time Frame Predose through 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Arm/Group Title LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliters (ng/mL)
60.2
(39%)
58.0
(36%)
6.Secondary Outcome
Title Pharmacokinetics: Observed Cmax of Alcohol
Hide Description [Not Specified]
Time Frame Predose through 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Arm/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: millimoles/liters (mmol/L)
11.4
(30%)
13.8
(22%)
7.Secondary Outcome
Title Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
Hide Description [Not Specified]
Time Frame Predose through 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Arm/Group Title LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 26 26
Median (Inter-Quartile Range)
Unit of Measure: hours
4.00
(1.85 to 5.92)
2.94
(1.08 to 5.92)
8.Secondary Outcome
Title Pharmacokinetics: Observed Tmax of Alcohol
Hide Description [Not Specified]
Time Frame Predose through 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Arm/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 26 26
Median (Inter-Quartile Range)
Unit of Measure: hours
0.92
(0.50 to 1.92)
0.92
(0.50 to 1.92)
9.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
Hide Description [Not Specified]
Time Frame Predose through 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Arm/Group Title LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 26 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hours/milliliters (ng*h/mL)
717
(41%)
678
(38%)
10.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol
Hide Description [Not Specified]
Time Frame Predose through 12 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Arm/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 27 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: millimoles*hours/liters (mmol*h/L)
29.7
(49%)
34.5
(43%)
11.Secondary Outcome
Title Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Hour 1
-0.12
(-0.2 to -0.03)
-0.12
(-0.21 to -0.04)
-0.1
(-0.19 to -0.02)
-0.02
(-0.1 to 0.07)
Hour 2
-0.27
(-0.42 to -0.12)
-0.29
(-0.44 to -0.14)
-0.13
(-0.28 to 0.02)
-0.12
(-0.27 to 0.03)
Hour 3
-0.2
(-0.34 to -0.07)
-0.18
(-0.31 to -0.05)
-0.06
(-0.19 to 0.08)
-0.04
(-0.17 to 0.09)
Hour 4.5
-0.15
(-0.29 to -0.01)
-0.11
(-0.25 to 0.03)
-0.2
(-0.34 to -0.06)
-0.2
(-0.35 to -0.06)
Hour 6
-0.1
(-0.2 to -0.01)
-0.09
(-0.19 to 0.01)
-0.06
(-0.16 to 0.03)
-0.07
(-0.17 to 0.02)
Hour 8
-0.03
(-0.15 to 0.08)
-0.05
(-0.17 to 0.06)
-0.08
(-0.19 to 0.04)
-0.13
(-0.24 to -0.01)
Hour 10
-0.21
(-0.35 to -0.07)
-0.09
(-0.23 to 0.06)
-0.16
(-0.3 to -0.01)
-0.06
(-0.21 to 0.08)
12.Secondary Outcome
Title Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Geometric Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Hour 1 Number Analyzed 27 participants 27 participants 26 participants 27 participants
-29.13
(-45.64 to -12.62)
-30.56
(-47.05 to -14.07)
-24.81
(-41.57 to -8.05)
-19.29
(-35.81 to -2.77)
Hour 2 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-96.35
(-115.59 to -77.11)
-97.54
(-116.76 to -78.32)
-44.3
(-63.53 to -25.07)
-41.64
(-60.88 to -22.39)
Hour 3 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-76.72
(-93.96 to -59.48)
-74.27
(-91.49 to -57.04)
-34.92
(-52.15 to -17.69)
-30.58
(-47.84 to -13.33)
Hour 4.5 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-65.06
(-82.57 to -47.55)
-52.23
(-69.73 to -34.74)
-50.78
(-68.28 to -33.28)
-34.29
(-51.81 to -16.77)
Hour 6 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-39.56
(-56.48 to -22.65)
-49.7
(-66.6 to -32.8)
-41.34
(-58.24 to -24.43)
-38.86
(-55.78 to -21.93)
Hour 8 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-42.28
(-58.63 to -25.93)
-43.65
(-59.98 to -27.32)
-46.09
(-62.43 to -29.75)
-35.95
(-52.31 to -19.6)
Hour 10 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-46.78
(-65.31 to -28.26)
-34.33
(-52.84 to -15.82)
-41.95
(-60.47 to -23.44)
-39.04
(-57.58 to -20.5)
13.Secondary Outcome
Title Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millisecond (msec)
Hour 1 Number Analyzed 27 participants 27 participants 26 participants 27 participants
-38.46
(-198.46 to 121.55)
36.22
(-123.97 to 196.4)
42.51
(-118.79 to 203.8)
138.87
(-21.27 to 299.02)
Hour 2 Number Analyzed 27 participants 27 participants 27 participants 27 participants
104.48
(-199.46 to 408.42)
316.09
(12.06 to 620.12)
59.65
(-244.29 to 363.59)
197.37
(-106.64 to 501.38)
Hour 3 Number Analyzed 27 participants 27 participants 27 participants 27 participants
43.69
(-215.33 to 302.7)
283.63
(24.51 to 542.75)
51.53
(-207.49 to 310.54)
24.55
(-234.55 to 283.65)
Hour 4.5 Number Analyzed 27 participants 27 participants 27 participants 27 participants
30.12
(-219.38 to 279.62)
61.93
(-187.69 to 311.54)
-121.55
(-371.06 to 127.96)
169.34
(-80.26 to 418.93)
Hour 6 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-116.69
(-266.39 to 33.01)
46.44
(-103.45 to 196.33)
-90.46
(-240.16 to 59.25)
-114.87
(-264.72 to 34.98)
Hour 8 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-116.72
(-315.54 to 82.11)
-48.13
(-247.09 to 150.84)
55.62
(-143.21 to 254.45)
-120.29
(-319.23 to 78.64)
Hour 10 Number Analyzed 27 participants 27 participants 27 participants 27 participants
-74.78
(-233.06 to 83.49)
-136.62
(-295.08 to 21.83)
-108.12
(-266.4 to 50.17)
-129.8
(-288.22 to 28.61)
14.Secondary Outcome
Title Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 27 27 27 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Self-rated Alertness, Hour 1 Number Analyzed 27 participants 27 participants 26 participants 27 participants
2.98
(-4.18 to 10.14)
4.57
(-2.59 to 11.73)
3.64
(-3.63 to 10.91)
6.06
(-1.13 to 13.25)
Self-rated Alertness, Hour 2 Number Analyzed 27 participants 27 participants 27 participants 27 participants
17.09
(8.81 to 25.37)
14.08
(5.8 to 22.36)
0.76
(-7.53 to 9.06)
3.64
(-4.67 to 11.94)
Self-rated Alertness, Hour 3 Number Analyzed 27 participants 27 participants 27 participants 27 participants
23.67
(15.05 to 32.3)
26.25
(17.63 to 34.87)
9.04
(0.41 to 17.67)
1.22
(-7.42 to 9.87)
Self-rated Alertness, Hour 4.5 Number Analyzed 27 participants 27 participants 27 participants 27 participants
27.19
(17.76 to 36.61)
20.74
(11.32 to 30.16)
16.26
(6.83 to 25.69)
9.82
(0.37 to 19.26)
Self-rated Alertness, Hour 6 Number Analyzed 27 participants 27 participants 27 participants 27 participants
23.66
(13.93 to 33.39)
17.25
(7.52 to 26.98)
15.13
(5.4 to 24.87)
7.55
(-2.2 to 17.3)
Self-rated Alertness, Hour 8 Number Analyzed 27 participants 27 participants 27 participants 27 participants
12.69
(3.75 to 21.63)
3.63
(-5.31 to 12.57)
12.38
(3.43 to 21.33)
3.03
(-5.93 to 11.99)
Self-rated Alertness, Hour 10 Number Analyzed 27 participants 27 participants 27 participants 27 participants
3.85
(-4.25 to 11.95)
-2.37
(-10.47 to 5.72)
11.88
(3.77 to 19.98)
3.02
(-5.1 to 11.14)
Self-rated Contentment, Hour 1 Number Analyzed 27 participants 27 participants 26 participants 27 participants
3.28
(-0.98 to 7.55)
0.95
(-3.32 to 5.22)
2.77
(-1.57 to 7.11)
4.34
(0.07 to 8.6)
Self-rated Contentment, Hour 2 Number Analyzed 27 participants 27 participants 27 participants 27 participants
3.72
(-2.72 to 10.16)
1.5
(-4.95 to 7.95)
1.64
(-4.81 to 8.09)
2.79
(-3.65 to 9.23)
Self-rated Contentment, Hour 3 Number Analyzed 27 participants 27 participants 27 participants 27 participants
8.41
(2.05 to 14.77)
7.12
(0.75 to 13.49)
5.69
(-0.67 to 12.06)
1.32
(-5.05 to 7.68)
Self-rated Contentment, Hour 4.5 Number Analyzed 27 participants 27 participants 27 participants 27 participants
16.98
(8.97 to 24.99)
8.5
(0.49 to 16.51)
11.39
(3.38 to 19.4)
5.03
(-2.98 to 13.03)
Self-rated Contentment, Hour 6 Number Analyzed 27 participants 27 participants 27 participants 27 participants
18.14
(9.12 to 27.17)
10.85
(1.82 to 19.88)
10.68
(1.65 to 19.71)
4.57
(-4.45 to 13.6)
Self-rated Contentment, Hour 8 Number Analyzed 27 participants 27 participants 27 participants 27 participants
9.97
(2.14 to 17.79)
0.98
(-6.85 to 8.81)
9.68
(1.86 to 17.51)
2.7
(-5.12 to 10.53)
Self-rated Contentment, Hour 10 Number Analyzed 27 participants 27 participants 27 participants 27 participants
2.47
(-5.14 to 10.07)
0.44
(-7.17 to 8.05)
10.16
(2.55 to 17.77)
3.72
(-3.89 to 11.32)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
LY2216684 + Placebo-matching Alcohol Placebo-matching LY2216684 + Placebo-matching Alcohol LY2216684 + Alcohol Placebo-matching LY2216684 + Alcohol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/27 (59.26%)      8/27 (29.63%)      10/27 (37.04%)      8/27 (29.63%)    
Cardiac disorders         
Palpitations  1  3/27 (11.11%)  3 0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Ear and labyrinth disorders         
Ear pain  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Eye disorders         
Eye irritation  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Lacrimation increased  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Visual impairment  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal disorders         
Abdominal pain  1  3/27 (11.11%)  4 2/27 (7.41%)  2 0/27 (0.00%)  0 0/27 (0.00%)  0
Constipation  1  5/27 (18.52%)  6 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Dry mouth  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Dyspepsia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Dysphagia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Eructation  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Haematochezia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Nausea  1  7/27 (25.93%)  7 0/27 (0.00%)  0 1/27 (3.70%)  1 2/27 (7.41%)  2
Vomiting  1  2/27 (7.41%)  2 0/27 (0.00%)  0 1/27 (3.70%)  1 1/27 (3.70%)  1
General disorders         
Asthenia  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Chills  1  4/27 (14.81%)  4 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Fatigue  1  0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Non-cardiac chest pain  1  0/27 (0.00%)  0 1/27 (3.70%)  1 2/27 (7.41%)  2 0/27 (0.00%)  0
Injury, poisoning and procedural complications         
Burns first degree  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Nervous system disorders         
Cognitive disorder  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Dizziness  1  4/27 (14.81%)  4 1/27 (3.70%)  1 1/27 (3.70%)  1 1/27 (3.70%)  1
Headache  1  3/27 (11.11%)  5 3/27 (11.11%)  3 1/27 (3.70%)  1 1/27 (3.70%)  1
Paraesthesia  1  4/27 (14.81%)  4 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Somnolence  1  4/27 (14.81%)  5 1/27 (3.70%)  2 1/27 (3.70%)  1 1/27 (3.70%)  1
Psychiatric disorders         
Anxiety  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Renal and urinary disorders         
Urinary hesitation  1  3/27 (11.11%)  3 0/27 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Reproductive system and breast disorders         
Dysmenorrhoea  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Menstruation irregular  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Pelvic pain  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Rhinitis allergic  1  0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0
Rhinorrhoea  1  1/27 (3.70%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
Vascular disorders         
Flushing  1  4/27 (14.81%)  4 0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01380691     History of Changes
Other Study ID Numbers: 12613
H9P-EW-LNCV ( Other Identifier: Eli Lilly and Company )
First Submitted: June 22, 2011
First Posted: June 27, 2011
Results First Submitted: February 17, 2018
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019