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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02864264 |
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Date of registration:
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09/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
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Scientific title:
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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 |
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Date of first enrolment:
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September 14, 2016 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02864264 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Georgia
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Moldova, Republic of
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Romania
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Healthy Volunteers
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Intervention(s)
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Drug: BMS-986184
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Drug: Placebo matching BMS-986184
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Primary Outcome(s)
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Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
[Time Frame: Up to 183 days]
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Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
[Time Frame: Up to 183 days]
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Composite of incidence, severity and outcome of all Adverse Events (AEs)
[Time Frame: Up to 183 days]
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Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
[Time Frame: Up to 183 days]
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Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
[Time Frame: Up to 183 days]
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Secondary ID(s)
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IM012-004
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2016-000895-72
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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