Inflammatory Bowel Diseases Clinical Trial
Official title:
A Single-centre, Randomized, Double-blind (Sponsor Open), Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2983559, in Single (in Both Fed and Fasted States) and Repeat Oral Doses in Healthy Participants
This study is the first administration of GSK2983559, a selective receptor interacting protein 2 (RIP2) kinase inhibitor, to humans. This will be randomized, double-blinded (sponsor open) and two part study (A and B). Part A of the study is single ascending dose crossover design with two separate cohorts (1 and 2). In Part A, 9 single dose levels will be explored. In Cohort 1, 10 healthy subjects will randomized to receive single oral doses of either GSK2983559 or placebo in a ratio of 4:1 in 5 way cross-over design with 5 treatment periods. In Cohort 2, 8 healthy subjects will be randomized to receive single oral doses of either GSK2983559 or placebo in a ratio of 3:1 in 4 way cross-overs design with 4 treatment periods. In Cohort 2 there will be an additional period (period 5-open label) for assessing GSK2983559 under fed conditions. There will be 48 hours wash-out period between each dose escalation period. Part B is repeat ascending dose sequential group design. It will contain 4 Cohorts of and dosing will be done sequential dosing. Subjects in Part B will receive once daily (QD) dose or twice daily dose (will be decided based upon the pharmacokinetic, safety and tolerability observed in Part A). There will 58 subjects involved in this study. Total duration of Part A will be approximately for 11 Weeks and Part B will be approximately for 15 Weeks.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
Active, not recruiting |
NCT04989907 -
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Active, not recruiting |
NCT04990258 -
A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
|
||
Enrolling by invitation |
NCT06015789 -
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
|
||
Recruiting |
NCT06065995 -
StoMakker Mobile Application
|
N/A | |
Recruiting |
NCT03282786 -
Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
|
N/A | |
Recruiting |
NCT06002074 -
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT04960826 -
Study of an Environmental Risk Factor in Crohn's Disease
|
||
Recruiting |
NCT05413941 -
Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease
|
N/A | |
Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
Completed |
NCT00721812 -
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
|
Phase 1 | |
Recruiting |
NCT05809999 -
IBD Neoplasia Surveillance RCT
|
N/A | |
Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
Recruiting |
NCT04991324 -
Cholecalciferol Comedication in IBD - the 5C-study
|
Phase 3 | |
Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
Not yet recruiting |
NCT05043818 -
A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
|
||
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Completed |
NCT02874365 -
Intestinal Stem Cells Characterization
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A |