Study Summary
This trial is testing a new drug, MK-6194, for safety, side effects, how it works in the body, and if it causes an immune reaction in people with active ulcerative colitis.
- Ulcerative Colitis
Treatment Effectiveness
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: Days 1, 29, 57, and 85
Trial Safety
Trial Design
2 Treatment Groups
MK-6194
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: MK-6194 · Has Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What goals does this experiment aspire to accomplish?
"This clinical trial, running for up to 85 days, is principally evaluating the number of participants discontinuing treatment due to adverse events. Secondary measures include the Area Under Curve from time zero to infinity (AUC0-inf) and Apparent Half Life (t1/2) of MK-6194 plasma concentration as well as Titer of anti-drug antibody against MK-6194." - Anonymous Online Contributor
How many locations are participating in the evaluation of this procedure?
"Patients interested in participating can do so at Southern Star Research Institute ( Site # 0101) in San Antonio, Texas, Pinnacle Clinical Research ( Site 0103) in Raleigh, North Carolina and Carolina's GI Research, LLC ( Site 0105) Rialto, California among 6 other sites." - Anonymous Online Contributor
Does the trial's protocol allow for individuals aged under 20 to participate?
"This medical study is open to adults over 18 years of age, up until the maximum enrolment cut-off point of 80." - Anonymous Online Contributor
What type of participant is eligible for this research initiative?
"Presently, this experiment is seeking 30 people with colitis aged between 18 and 80. Individuals that are accepted must meet the following criteria: a diagnosis of UC at least three months beforehand; mildly to severely active UC; inadequate response or intolerance to one prior conventional therapy and no more than two advanced therapies; those over 50 years old need documentation for colonoscopy in the last 3 years excluding adenomatous polyps (if excised then eligible); extensive colitis history of 8 years or left side colon involvement 10+ year needs full colonoscopy 1year pre study drug administration or screening visit respectively; lack of latent/active" - Anonymous Online Contributor
What is the sample size for this medical experiment?
"This trial requires 30 volunteers who are eligible for inclusion. Participants can join from Southern Star Research Institute (Site # 0101) in San Antonio, TX or Pinnacle Clinical Research ( Site 0103) in Raleigh, NC." - Anonymous Online Contributor
Has the regulatory body approved MK-6194 for human use?
"Due to the limited clinical data regarding MK-6194's safety and efficacy, our team gave it a score of 1 on a scale from 1 to 3." - Anonymous Online Contributor
Is this trial still recruiting participants?
"The data available on clinicaltrials.gov indicates that this research project is still actively seeking applicants; it was originally posted in October 2021 and the information was last edited in November of 2022." - Anonymous Online Contributor