A Study of Experimental Medication BMS-986235 in Healthy Subjects
NCT ID: NCT03335553
Last Updated: 2022-03-31
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
122 participants
INTERVENTIONAL
2017-11-15
2021-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Single ascending dose (SAD): BMS-986235 or Placebo
BMS-986235 or Placebo oral dose
BMS-986235
Specified dose on specified days
Placebo
Specified dose on specified days
Multiple ascending dose (MAD): BMS-986235 or Placebo
BMS-986235 or Placebo oral dose
BMS-986235
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986235
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive
Exclusion Criteria
* Patient with any significant acute or chronic medical illness
* Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* Patient with any surgery within 12 weeks of study treatment administration
* Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
* Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
* Patient who received a blood transfusion within 12 weeks of study drug administration
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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Anaheim Clinical Trials
Anaheim, California, United States
PRA Health Sciences
Salt Lake City, Utah, United States
Countries
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References
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Singh J, Jackson KL, Fang H, Gumanti A, Claridge B, Tang FS, Kiriazis H, Salimova E, Parker AM, Nowell C, Woodman OL, Greening DW, Ritchie RH, Head GA, Qin CX. Novel formylpeptide receptor 1/2 agonist limits hypertension-induced cardiovascular damage. Cardiovasc Res. 2024 Sep 21;120(11):1336-1350. doi: 10.1093/cvr/cvae103.
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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CV018-001
Identifier Type: -
Identifier Source: org_study_id
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