Trial Outcomes & Findings for A Study of LY2216684 in Healthy Participants (NCT NCT01380691)
NCT ID: NCT01380691
Last Updated: 2019-06-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline, 10 hours
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
7
|
7
|
7
|
7
|
|
Washout (7 Days)
COMPLETED
|
7
|
7
|
6
|
6
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
|
Period 2
STARTED
|
7
|
7
|
6
|
6
|
|
Period 2
COMPLETED
|
7
|
7
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Washout (7 Days)
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Washout (7 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY2216684 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=28 Participants
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.
|
|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 hoursPopulation: 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.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline to 10 Hours in Power of Attention Composite Score
|
67.82 minutes
Interval 22.01 to 113.63
|
52.77 minutes
Interval 7.05 to 98.5
|
20.6 minutes
Interval -25.13 to 66.33
|
6.78 minutes
Interval -39.13 to 52.69
|
PRIMARY outcome
Timeframe: Baseline, 10 hoursPopulation: 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.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline to 10 Hours in Continuity of Attention Composite Score
|
-4.21 units on a scale
Interval -6.98 to -1.43
|
-1.16 units on a scale
Interval -3.93 to 1.61
|
-3.31 units on a scale
Interval -6.08 to -0.54
|
-1.24 units on a scale
Interval -4.0 to 1.53
|
PRIMARY outcome
Timeframe: Baseline, 10 hoursPopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable postural stability data.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline to 10 Hours in Postural Stability
|
0.14 1/3 degree of angle of sway
Interval -5.38 to 5.66
|
-3.51 1/3 degree of angle of sway
Interval -9.03 to 2.0
|
-3.65 1/3 degree of angle of sway
Interval -9.17 to 1.87
|
5.2 1/3 degree of angle of sway
Interval -0.32 to 10.72
|
PRIMARY outcome
Timeframe: Baseline, 10 hoursPopulation: 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.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline to 10 Hours in Self-Rated Alertness
|
3.85 units on a scale
Interval -4.25 to 11.95
|
-2.37 units on a scale
Interval -10.47 to 5.72
|
11.88 units on a scale
Interval 3.77 to 19.98
|
3.02 units on a scale
Interval -5.1 to 11.14
|
SECONDARY outcome
Timeframe: Predose through 24 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
|
60.2 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 39
|
58.0 nanograms/milliliters (ng/mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose through 24 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Pharmacokinetics: Observed Cmax of Alcohol
|
11.4 millimoles/liters (mmol/L)
Geometric Coefficient of Variation 30
|
13.8 millimoles/liters (mmol/L)
Geometric Coefficient of Variation 22
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose through 24 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=26 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.
|
Placebo-matching LY2216684 + Alcohol
n=26 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
|
4.00 hours
Interval 1.85 to 5.92
|
2.94 hours
Interval 1.08 to 5.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose through 24 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=26 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.
|
Placebo-matching LY2216684 + Alcohol
n=26 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Pharmacokinetics: Observed Tmax of Alcohol
|
0.92 hours
Interval 0.5 to 1.92
|
0.92 hours
Interval 0.5 to 1.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose through 24 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=26 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
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
|
678 nanograms*hours/milliliters (ng*h/mL)
Geometric Coefficient of Variation 38
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose through 12 hours postdosePopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
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
|
34.5 millimoles*hours/liters (mmol*h/L)
Geometric Coefficient of Variation 43
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hoursPopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable working memory data.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
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
Interval -0.29 to -0.01
|
-0.11 Units on a scale
Interval -0.25 to 0.03
|
-0.2 Units on a scale
Interval -0.34 to -0.06
|
-0.2 Units on a scale
Interval -0.35 to -0.06
|
|
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
Interval -0.2 to -0.03
|
-0.12 Units on a scale
Interval -0.21 to -0.04
|
-0.1 Units on a scale
Interval -0.19 to -0.02
|
-0.02 Units on a scale
Interval -0.1 to 0.07
|
|
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
Interval -0.42 to -0.12
|
-0.29 Units on a scale
Interval -0.44 to -0.14
|
-0.13 Units on a scale
Interval -0.28 to 0.02
|
-0.12 Units on a scale
Interval -0.27 to 0.03
|
|
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
Interval -0.34 to -0.07
|
-0.18 Units on a scale
Interval -0.31 to -0.05
|
-0.06 Units on a scale
Interval -0.19 to 0.08
|
-0.04 Units on a scale
Interval -0.17 to 0.09
|
|
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
Interval -0.2 to -0.01
|
-0.09 Units on a scale
Interval -0.19 to 0.01
|
-0.06 Units on a scale
Interval -0.16 to 0.03
|
-0.07 Units on a scale
Interval -0.17 to 0.02
|
|
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
Interval -0.15 to 0.08
|
-0.05 Units on a scale
Interval -0.17 to 0.06
|
-0.08 Units on a scale
Interval -0.19 to 0.04
|
-0.13 Units on a scale
Interval -0.24 to -0.01
|
|
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
Interval -0.35 to -0.07
|
-0.09 Units on a scale
Interval -0.23 to 0.06
|
-0.16 Units on a scale
Interval -0.3 to -0.01
|
-0.06 Units on a scale
Interval -0.21 to 0.08
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hoursPopulation: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable episodic memory data.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
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
Interval -82.57 to -47.55
|
-52.23 units on a scale
Interval -69.73 to -34.74
|
-50.78 units on a scale
Interval -68.28 to -33.28
|
-34.29 units on a scale
Interval -51.81 to -16.77
|
|
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
Interval -45.64 to -12.62
|
-30.56 units on a scale
Interval -47.05 to -14.07
|
-24.81 units on a scale
Interval -41.57 to -8.05
|
-19.29 units on a scale
Interval -35.81 to -2.77
|
|
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
Interval -115.59 to -77.11
|
-97.54 units on a scale
Interval -116.76 to -78.32
|
-44.3 units on a scale
Interval -63.53 to -25.07
|
-41.64 units on a scale
Interval -60.88 to -22.39
|
|
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
Interval -93.96 to -59.48
|
-74.27 units on a scale
Interval -91.49 to -57.04
|
-34.92 units on a scale
Interval -52.15 to -17.69
|
-30.58 units on a scale
Interval -47.84 to -13.33
|
|
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
Interval -56.48 to -22.65
|
-49.7 units on a scale
Interval -66.6 to -32.8
|
-41.34 units on a scale
Interval -58.24 to -24.43
|
-38.86 units on a scale
Interval -55.78 to -21.93
|
|
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
Interval -58.63 to -25.93
|
-43.65 units on a scale
Interval -59.98 to -27.32
|
-46.09 units on a scale
Interval -62.43 to -29.75
|
-35.95 units on a scale
Interval -52.31 to -19.6
|
|
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
Interval -65.31 to -28.26
|
-34.33 units on a scale
Interval -52.84 to -15.82
|
-41.95 units on a scale
Interval -60.47 to -23.44
|
-39.04 units on a scale
Interval -57.58 to -20.5
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hoursPopulation: 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.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
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)
Interval -198.46 to 121.55
|
36.22 millisecond (msec)
Interval -123.97 to 196.4
|
42.51 millisecond (msec)
Interval -118.79 to 203.8
|
138.87 millisecond (msec)
Interval -21.27 to 299.02
|
|
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)
Interval -199.46 to 408.42
|
316.09 millisecond (msec)
Interval 12.06 to 620.12
|
59.65 millisecond (msec)
Interval -244.29 to 363.59
|
197.37 millisecond (msec)
Interval -106.64 to 501.38
|
|
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)
Interval -215.33 to 302.7
|
283.63 millisecond (msec)
Interval 24.51 to 542.75
|
51.53 millisecond (msec)
Interval -207.49 to 310.54
|
24.55 millisecond (msec)
Interval -234.55 to 283.65
|
|
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)
Interval -219.38 to 279.62
|
61.93 millisecond (msec)
Interval -187.69 to 311.54
|
-121.55 millisecond (msec)
Interval -371.06 to 127.96
|
169.34 millisecond (msec)
Interval -80.26 to 418.93
|
|
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)
Interval -266.39 to 33.01
|
46.44 millisecond (msec)
Interval -103.45 to 196.33
|
-90.46 millisecond (msec)
Interval -240.16 to 59.25
|
-114.87 millisecond (msec)
Interval -264.72 to 34.98
|
|
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)
Interval -315.54 to 82.11
|
-48.13 millisecond (msec)
Interval -247.09 to 150.84
|
55.62 millisecond (msec)
Interval -143.21 to 254.45
|
-120.29 millisecond (msec)
Interval -319.23 to 78.64
|
|
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)
Interval -233.06 to 83.49
|
-136.62 millisecond (msec)
Interval -295.08 to 21.83
|
-108.12 millisecond (msec)
Interval -266.4 to 50.17
|
-129.8 millisecond (msec)
Interval -288.22 to 28.61
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hoursPopulation: 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.
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.
Outcome measures
| Measure |
LY2216684 + Alcohol
n=27 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.
|
Placebo-matching LY2216684 + Alcohol
n=27 Participants
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.
|
LY2216684 + Placebo-matching Alcohol
n=27 Participants
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 + Placebo-matching Alcohol
n=27 Participants
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.
|
|---|---|---|---|---|
|
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
Interval 13.93 to 33.39
|
17.25 units on a scale
Interval 7.52 to 26.98
|
15.13 units on a scale
Interval 5.4 to 24.87
|
7.55 units on a scale
Interval -2.2 to 17.3
|
|
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
Interval -4.18 to 10.14
|
4.57 units on a scale
Interval -2.59 to 11.73
|
3.64 units on a scale
Interval -3.63 to 10.91
|
6.06 units on a scale
Interval -1.13 to 13.25
|
|
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
Interval 8.81 to 25.37
|
14.08 units on a scale
Interval 5.8 to 22.36
|
0.76 units on a scale
Interval -7.53 to 9.06
|
3.64 units on a scale
Interval -4.67 to 11.94
|
|
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
Interval 15.05 to 32.3
|
26.25 units on a scale
Interval 17.63 to 34.87
|
9.04 units on a scale
Interval 0.41 to 17.67
|
1.22 units on a scale
Interval -7.42 to 9.87
|
|
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
Interval 17.76 to 36.61
|
20.74 units on a scale
Interval 11.32 to 30.16
|
16.26 units on a scale
Interval 6.83 to 25.69
|
9.82 units on a scale
Interval 0.37 to 19.26
|
|
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
Interval 3.75 to 21.63
|
3.63 units on a scale
Interval -5.31 to 12.57
|
12.38 units on a scale
Interval 3.43 to 21.33
|
3.03 units on a scale
Interval -5.93 to 11.99
|
|
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
Interval -4.25 to 11.95
|
-2.37 units on a scale
Interval -10.47 to 5.72
|
11.88 units on a scale
Interval 3.77 to 19.98
|
3.02 units on a scale
Interval -5.1 to 11.14
|
|
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
Interval -0.98 to 7.55
|
0.95 units on a scale
Interval -3.32 to 5.22
|
2.77 units on a scale
Interval -1.57 to 7.11
|
4.34 units on a scale
Interval 0.07 to 8.6
|
|
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
Interval -2.72 to 10.16
|
1.5 units on a scale
Interval -4.95 to 7.95
|
1.64 units on a scale
Interval -4.81 to 8.09
|
2.79 units on a scale
Interval -3.65 to 9.23
|
|
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
Interval 2.05 to 14.77
|
7.12 units on a scale
Interval 0.75 to 13.49
|
5.69 units on a scale
Interval -0.67 to 12.06
|
1.32 units on a scale
Interval -5.05 to 7.68
|
|
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
Interval 8.97 to 24.99
|
8.5 units on a scale
Interval 0.49 to 16.51
|
11.39 units on a scale
Interval 3.38 to 19.4
|
5.03 units on a scale
Interval -2.98 to 13.03
|
|
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
Interval 9.12 to 27.17
|
10.85 units on a scale
Interval 1.82 to 19.88
|
10.68 units on a scale
Interval 1.65 to 19.71
|
4.57 units on a scale
Interval -4.45 to 13.6
|
|
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
Interval 2.14 to 17.79
|
0.98 units on a scale
Interval -6.85 to 8.81
|
9.68 units on a scale
Interval 1.86 to 17.51
|
2.7 units on a scale
Interval -5.12 to 10.53
|
|
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
Interval -5.14 to 10.07
|
0.44 units on a scale
Interval -7.17 to 8.05
|
10.16 units on a scale
Interval 2.55 to 17.77
|
3.72 units on a scale
Interval -3.89 to 11.32
|
Adverse Events
LY2216684 + Placebo-matching Alcohol
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo-matching LY2216684 + Placebo-matching Alcohol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2216684 + Alcohol
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo-matching LY2216684 + Alcohol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2216684 + Placebo-matching Alcohol
n=27 participants at risk
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 + Placebo-matching Alcohol
n=27 participants at risk
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.
|
LY2216684 + Alcohol
n=27 participants at risk
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 + Alcohol
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
11.1%
3/27 • Number of events 3
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
Eye irritation
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Eye disorders
Visual impairment
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
3/27 • Number of events 4
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Constipation
|
18.5%
5/27 • Number of events 6
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • Number of events 7
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Chills
|
14.8%
4/27 • Number of events 4
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
General disorders
Fatigue
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
Cognitive disorder
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 5
|
11.1%
3/27 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
14.8%
4/27 • Number of events 4
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Nervous system disorders
Somnolence
|
14.8%
4/27 • Number of events 5
|
3.7%
1/27 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Renal and urinary disorders
Urinary hesitation
|
11.1%
3/27 • Number of events 3
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
Flushing
|
14.8%
4/27 • Number of events 4
|
0.00%
0/27
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60