Clinical trial NCT02864264: Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Ulcerative Colitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
timeFrame: Up to 183 days
measure: Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
timeFrame: Up to 183 days
measure: Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
timeFrame: Up to 183 days
measure: Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
timeFrame: Up to 183 days
measure: Composite of incidence, severity and outcome of all Adverse Events (AEs)
timeFrame: Up to 183 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Tbilisi
country: Georgia
facility: Local Institution
city: Chisinau
country: Moldova, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: