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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
Health authority
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

Study Design


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
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