A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Other: Placebo (for BMS-986308)

Drug: BMS-986308

Drug: Furosemide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04763226

CV021-004

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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 Criteria:

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