A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
NCT ID: NCT04763226
Last Updated: 2022-04-27
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
46 participants
INTERVENTIONAL
2021-04-14
2022-02-27
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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Part A Furosemide
Furosemide
Specified dose on specified days
Part B (SAD)
Single Ascending Dose (SAD)
BMS-986308
Specified dose on specified days
Placebo (for BMS-986308)
Specified dose on specified days
Interventions
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BMS-986308
Specified dose on specified days
Placebo (for BMS-986308)
Specified dose on specified days
Furosemide
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Must have a body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, at screening. BMI = weight (kg)/height (m)\^2
* Must have normal renal function at screening (and study admission) as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
Exclusion Criteria
* Presence or need for urinary catheterization, urinary tract abnormality, or disorder interfering with urination
* History of tinnitus or hearing impairment, including deafness
* History or risks factors for Torsade de Pointes and Long QT syndrome (such as electrolyte imbalances, etc)
* History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* Consumption of caffeine or xanthine-containing food or beverages within 72 hours prior to study treatment administration
* Use of any prescription drugs or over-the-counter (OTC) acid controllers within 4 weeks prior to study treatment administration except those medications cleared by the Medical Monitor
* Use of any other drugs, including OTC medications within 1 week and herbal preparations, within 2 weeks prior to study treatment administration except those medications cleared by the Medical Monitor
* Use of diuretics (loop diuretics, thiazide diuretics, potassium-sparing diuretics \[spironolactone, amiloride\]), oral calcium, potassium or magnesium supplements (including multi-vitamins) or use of non-steroidal anti-inflammatory drugs within 72 hours of the first study treatment
* Use of concomitant medications that are strong inhibitors or inducers of cytochrome CYP3A4 or OATP administered within 2 weeks prior to study treatment administration and throughout the study
* Consumption of any nutrients known to modulate cytochrome P450 (CYP) enzymes activity (eg, grapefruit, or grapefruit juice,pomelo juice, star fruit, or Seville \[blood\] orange products) within 14 days prior to first administration of study treatment
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population of healthy volunteers
* History of allergy to furosemide, sulfonamides, other loop diuretics (furosemide cohort only), BMS-986308 or related compounds, components of the suspension or solution, including hydroxypropylmethylcellulose
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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Local Institution - 0001
Lenexa, Kansas, 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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CV021-004
Identifier Type: -
Identifier Source: org_study_id
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