Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Healthy Volunteers Clinical Trial

Official title:

Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02864264
• Other study ID #: IM012-004
• Secondary ID: 2016-000895-72
• Status: Terminated
• Phase: Phase 1
• First received: August 9, 2016
• Last updated: October 19, 2017
• Start date: September 14, 2016
• Est. completion date: September 27, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug

• Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis)

Exclusion Criteria:

• Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C

• Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Healthy Volunteers
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BMS-986184

• Placebo matching BMS-986184

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria
Georgia	Local Institution	Tbilisi
Moldova, Republic of	Local Institution	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Georgia,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements		Up to 183 days
Primary	Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings		Up to 183 days
Primary	Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results		Up to 183 days
Primary	Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments		Up to 183 days
Primary	Composite of incidence, severity and outcome of all Adverse Events (AEs)		Up to 183 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form