A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System (CNS) Depressant Drug Users
Sponsor study identifier
interventional
42
0 countries
N/A
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)This was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
February 2010
Actual (reported)February 2010
Actual (reported)November 13, 2013
Actual (reported)November 19, 2013
Actual (reported)Maximum effect (Emax) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit
Emax was determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented a 'Strong disliking' and a score of '100' represented a 'Strong liking'.
24 hours
Minimum Effect (Emin) and Time-weighted mean effect (TWMean) over 24 h post-dose for "At the moment" Drug Liking VAS score during each Treatment Visit
24 hours
Overall Drug Liking VAS score (Emax, Emin, and arithmetic mean effect of 8 h and 24 h post-dose assessments during each Treatment Visit)
24 hours
Good/Bad Drug Effects VAS score (Emax, Emin, and TWMean over 24 h post-dose during each Treatment Visit)
24 hours
Take Drug Again VAS score (Emax and arithmetic mean of 8 h and 24 h post-dose assessments during each Treatment Visit)
24 hours
Subjective Drug Value (SDV) (Emax and arithmetic mean of 8 h and 24 h post-dose assessment during each Treatment Visit)
24 hours
Subjects were randomized to receive single, oral doses of study medication in the sequence ABFCED, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Edward M Sellers, MD, PhD
Kendle Early Stage - Toronto
42 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2013
First Posted
November 19, 2013
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
A Study of LY2624803 in Participants With Transient Insomnia
Subjects were randomized to receive single, oral doses of study medication in the sequence BCADFE, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Subjects were randomized to receive single, oral doses of study medication in the sequence CDBEAF, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Subjects were randomized to receive single, oral doses of study medication in the sequence DECFBA, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Subjects were randomized to receive single, oral doses of study medication in the sequence EFDACB, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Subjects were randomized to receive single, oral doses of study medication in the sequence FAEBDC, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days.
Contact the study team to confirm eligibility.
Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
February 12, 2016
Record last verified: 2016-02
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