A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
NCT ID: NCT04154800
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2019-12-06
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part A:SAD
Single Ascending Dose
BMS-986209
Specified Dose on Specified Days
Part B: MAD
Multiple Ascending Dose
BMS-986209
Specified Dose on Specified Days
Part C: DDI
Drug-Drug Interaction
BMS-986209
Specified Dose on Specified Days
Itraconazole
Specified Dose on Specified Days
Diltiazem
Specified Dose on Specified Days
Part A (SAD) Placebo
BMS-986209 Placebo
Specified Dose on Specified Days
Part B (MAD) Placebo
BMS-986209 Placebo
Specified Dose on Specified Days
Interventions
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BMS-986209
Specified Dose on Specified Days
BMS-986209 Placebo
Specified Dose on Specified Days
Itraconazole
Specified Dose on Specified Days
Diltiazem
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* Women and men must agree to follow specific methods of contraception if applicable.
* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
Exclusion Criteria
* Women who are breastfeeding
* Any acute or chronic medical illness
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
* History of heart disease or conduction disorders
* Head injury in the last 2 years, intracranial tumor, or aneurysm
* Known abdominal aneurysm
* Current or history of rectal bleeding, hematemesis, or hematuria
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PPD Development, LP
Austin, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV017-003
Identifier Type: -
Identifier Source: org_study_id
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