A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT04763226
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B (SAD) Placebo (for BMS-986308) Single Ascending Dose (SAD) Part B (SAD) BMS-986308 Single Ascending Dose (SAD) Part A Furosemide Furosemide -
- Primary Outcome Measures
Name Time Method Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 19 days Part B
Incidence of clinically significant changes in vital signs: Respiratory rate Up to 19 days Part B
Incidence of clinically significant changes in vital signs: Supine blood pressure Up to 19 days Part B
Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure Up to 19 days Part B
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 19 days Part B
PR interval is the time from the onset of the P wave to the start of the QRS complexIncidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS Up to 19 days Part B
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarizationIncidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 19 days Part B
The QT interval is the time from the start of the Q wave to the end of the T waveIncidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF Up to 19 days Part B
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T waveIncidence of clinically significant changes in cardiac telemetry Up to 19 days Part B
Incidence of clinically significant changes in physical examination findings Up to 19 days Part B
Incidence of Adverse Events (AEs) Up to 19 days Part B
Incidence of serious adverse events (SAEs) Up to 19 days Part B
Incidence of death Up to 19 days Part B
Incidence of adverse events (AEs) leading to discontinuation Up to 19 days Part B
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 19 days Part B
Incidence of clinically significant changes in vital signs: Heart rate Up to 19 days Part B
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 19 days Part B
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Lenexa, Kansas, United States