Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986308 compared to placebo in healthy participants.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Must be in good health, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- 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
- Any significant acute or chronic medical illness
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04763226
Start Date
April 14 2021
End Date
February 27 2022
Last Update
April 27 2022
Active Locations (1)
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1
Local Institution - 0001
Lenexa, Kansas, United States, 66219