A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
NCT ID: NCT03254784
Last Updated: 2020-02-25
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
49 participants
INTERVENTIONAL
2017-09-13
2017-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Tablet-Capsule Crossover 1
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Tablet-Capsule Crossover 2
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Tablet-Capsule Crossover 3
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Tablet-Capsule Crossover 4
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Tablet-Capsule Crossover 5
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Tablet-Capsule Crossover 6
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Interventions
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BMS-986165 Capsule
Oral capsule
BMS-986165 Tablet
Oral tablet
Eligibility Criteria
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Inclusion Criteria
* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
* Normal renal function at screening
Exclusion Criteria
* Any significant acute or chronic medical illness
* History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
* History of headaches related to caffeine withdrawal, including energy drinks
* History of syncope, orthostatic instability, or recurrent dizziness
* Active TB requiring treatment or documented latent TB within the previous 3 years
18 Years
50 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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PRA Health Sciences
Lenexa, Kansas, United States
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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IM011-031
Identifier Type: -
Identifier Source: org_study_id
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