Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.
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|ClinicalTrials.gov Identifier: NCT02000453|
Recruitment Status : Terminated (GSK has elected to terminate development principally as a result of the statin drug-drug interaction (DDI) study.)
First Posted : December 4, 2013
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: GSK2586184 400mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.|
|Actual Study Start Date :||December 20, 2013|
|Actual Primary Completion Date :||August 8, 2014|
|Actual Study Completion Date :||August 8, 2014|
A total of 15 subjects to be administered 400 mg GSK2586184 Tablet (200 mg X 2) twice daily for up to 56 days
Drug: GSK2586184 400mg
White film coated round biconvex GSK2586184 200 mg tablets, administered 2 X twice daily. Tablet containing GSK2586184A, with the following excipients: microcrystalline cellulose, lactose, hypromellose, croscarmellose sodium, magnesium stearate and titanium dioxide.
- Safety and Tolerability of twice daily doses of GSK2586184 [ Time Frame: Up to Week 8 ]Safety and tolerability, as determined by laboratory tests (including haematology, clinical chemistry and serum creatinine) vital signs, 12-lead Electrocardiogram (ECG), physical examination, and adverse event reporting.
- Safety as assessed by the collection of adverse events (AEs) [ Time Frame: Up to Week 8 ]AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
- Safety as assessed by laboratory parameters [ Time Frame: Up to Week 8 ]Laboratory parameters include hematology, clinical chemistry, urinalysis Absolute values and changes over time of hematology, clinical chemistry, urinalysis will be assessed.
- Safety as assessed by vital sign measurement [ Time Frame: Up to Week 8 ]Vital signs include systolic blood pressure, diastolic blood pressure, temperature, and heart rate.
- Safety as assessed by ECG rhythm. [ Time Frame: Up to Week 8 ]Continuous monitoring of a subject' heart rate and rhythm by ECG.
- Efficacy of GSK2586184 in achieving clinical and endoscopic remission after 8 weeks of treatment [ Time Frame: Up to Week 8 ]Efficacy assessed by total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point, and reduction in endoscopic mucosal appearance score of >= 1.
- Efficacy of GSK2586184 in achieving symptomatic clinical remission after 8 weeks [ Time Frame: Up to Week 8 ]Efficacy assessed by Mayo score for the proportion of subjects who achieve a score of 0 for both rectal bleeding and stool frequency.
- Efficacy of GSK2586184 in achieving clinical response [ Time Frame: Up to Week 8 ]Efficacy assessed by Mayo score for the proportion of subjects of subjects who achieve a decrease from baseline in total Mayo score of >=3 points, with an accompanying decrease in the sub score for rectal bleeding of at least 1 point or an absolute sub score for rectal bleeding
- Efficacy of GSK2586184 in achieving mucosal healing. [ Time Frame: Up to Week 8 ]Efficacy assessed by proportion of subjects who achieve an absolute sub score for endoscopy of 0 or 1, at week 8. And change from baseline of mucosal appearance determined by ulcerative colitis endoscopic index of severity (UCEIS).
- The effect of twice daily doses of GSK2586184 on health related quality of life (QoL) in UC patients. [ Time Frame: Up to Week 8 ]Change from baseline of inflammatory bowel disease questionnaire (IBDQ) was assessed
- The effect of twice daily doses of GSK2586184 on serum C reactive protein (CRP) levels in UC patients [ Time Frame: Up to Week 8 ]Change from baseline in mean serum CRP levels was assessed.
- The effect of twice daily doses of GSK2586184 on faecal calprotectin levels [ Time Frame: Up to Week 8 ]Change from baseline of mean faecal calprotectin levels was assessed.
- The plasma pharmacokinetics of repeated, twice daily doses of GSK2586184 [ Time Frame: Up to Week 8 ]Plasma concentrations and derived pharmacokinetic parameters of GSK2586184 were assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000453
|GSK Investigational Site|
|Amsterdam, Netherlands, 1105 AZ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|