A Phase 1 interventional study of GSK1482160 or placebo in Pain, Inflammatory, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-07.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. At different doses, we will look to see how much of the drug gets into the bloodstream, how the drug is broken down and excreted and whether this is affected by the presence of food.
GSK1482160 is a new drug to be developed for treating inflammatory pain (for example, arthritis). It acts on structures on inflammatory cells, known as P2X7 receptors. Blocking these receptors reduces the release of important inflammatory chemicals which exists within the body and are thought to play an important role in promoting inflammatory pain.
This study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy male or female volunteers will be enrolled into the study. In addition, part of the study will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This part of the study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (i.e. possible presence of any side effects that make taking the drug unpleasant) of increasing the study drug. Effects will be compared to those seen when a placebo is taken. Up to 3 groups of 8 healthy male and female volunteers may be enrolled.
Drug: GSK1482160 or placebo
If an investigation of food effect is not possible in Cohorts 2 or 3, this Cohort will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
Drug: GSK1482160 or placebo
GSK1482160 is a P2X7 receptor antagonist
Safety parameters, adverse events, change from baseline and number of subjects outside the normal range for blood pressure, heart rate, 12-lead electrocardiogram (ECG) and clinical laboratory parameters.
Time frame: Throughout study
Levels of GSK1482160 and any breakdown products in the blood and urine.
Time frame: Throughout study
Measuring the amount of inhibition of inflammatory chemical release from blood following dosing with GSK1482160.
Time frame: Throughout study
Levels of GSK1482160 and any breakdown products in the blood and urine when taken with and without food.
Time frame: Throughout study
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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