A Phase 1 interventional study of single dose in Alcoholism, sponsored by GlaxoSmithKline. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 21 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Drug: single dose
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo.
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Time frame: pre and post study drug administration
alcohol level
Time frame: during and post alcohol administration
blood level of GSK1144814
Time frame: pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Time frame: throughout the study pre- and post dose
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline