This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Evansville, Indiana, United States
Change From Baseline to 10 Hours in Power of Attention Composite Score
Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Change From Baseline to 10 Hours in Continuity of Attention Composite Score
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Change From Baseline to 10 Hours in Postural Stability
The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway. The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
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Administered orally
Time frame: Baseline, 10 hours
Change From Baseline to 10 Hours in Self-Rated Alertness
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 10 hours
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Cmax of Alcohol
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Tmax of Alcohol
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol
Time frame: Predose through 12 hours postdose
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks known as the sensitivity index (SI). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. A series of 5 digits were presented on a computer screen, every second, for the participant to hold in memory. Followed by 30 probe digits, the participant had to decide whether it appeared in the original series by responding with 'Yes' or 'No'. This was repeated 2 times using different series and probes. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
Episodic memory is based on how accurate the participant responds using the measures from immediate word recall (range 0-15), delayed word recall (range 0-15), word recognition (range 0-15), and picture recognition (range 0-20) tasks. The sum of four the accuracy scores, are summed, and averaged to provide a composite score (range 0-37.5). This composite score reflects the ability to store, hold, and retrieve information of an episodic nature (such as an event, a name, an object, a scene, or an appointment). A high score reflects someone able to recall memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
Speed of retrieval is a measure of complex information processing speed, summing reaction times from the two working memory (numeric and spatial) tasks and the two episodic recognition (word recognition and picture recognition) tasks. This composite score reflects the time it takes to decide correctly whether an item is held in working memory or episodic secondary memory.Scores are measured by response latencies, and smaller scores indicate better function. A negative change from baseline reflects impairment compared to baseline. LS means calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment\*time as fixed effects and participant within sequence and treatment as random effect.
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours