A Phase 1 interventional study of GSK598809 and Placebo in Substance Dependence, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-31.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 104 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Subjects will be randomized to receive either GSK598809 10 mg or Placebo.
Drug: GSK598809 · Drug: Placebo
Subjects will be randomized to receive either GSK598809 25 mg or Placebo.
Drug: GSK598809 · Drug: Placebo
Subjects will be randomized to receive either GSK598809 25 mg or Placebo.
Drug: GSK598809 · Drug: Placebo
Subjects will be randomized to receive either GSK598809 40 mg or Placebo.
Drug: GSK598809 · Drug: Placebo
Subjects will be randomized to receive either ascending doses of GSK598809 75, 120 and 175 mg or Placebo. There will be a washout period of 6 days between the doses.
Drug: GSK598809 · Drug: Placebo
Subjects will receive caffeine on day -1 and after randomization subject will either receive GSK598809 or Placebo on Day 1. After washout period of 1-week subject will either receive GSK598809 or Placebo for 28 days.
Drug: GSK598809 · Drug: Placebo · Drug: Caffeine
GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
Also known as: GSK598809/Placebo
Subjects will receive matching placebo capsules to GSK598809 orally with water.
Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose
Time frame: Up to Day 39
Tests on cognition (thinking) for 24 hours after dosing
Time frame: Up to Day 36
Akathisia assessment
Time frame: Up to Day 36
Involuntary Movements
Time frame: Up to Day 36
Simpson Angus Scale (SAS)
Time frame: Up to Day 36
Serum prolactin, GH and thyroid stimulating hormone (TSH), total and free testosterone, LH and FSH concentrations as possible
Time frame: Up to Day 39
Psychological assessment
Time frame: Up to Day 36
Cognition/impulsivity:
Time frame: Up to Day 35
Pharmacokinetics:
Time frame: Up to Day 38
GSK685249 levels to derive pharmacokinetic parameter
Time frame: Up to Day 38
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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