Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.
Status:
Terminated
Trial end date:
2014-08-08
Target enrollment:
Participant gender:
Summary
This is an open label exploratory study to investigate the safety of 400 milligram (mg )
twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative
colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up
to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6
out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week
2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows
for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the
safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory
tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead
electrocardiogram (ECG), physical examination, and adverse event reporting. These are
standard measurements to evaluate safety.