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

NCT04763226 | Completed Phase 1 FDA Drug

• 1 other identifier: CV021-004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

BMS-986308; Congestive heart failure (CHF); Diuretics; Diuretic resistance; Fluid overload; Furosemide; Persistent congestion

Outcome Measures

Primary Outcomes (17)

• Incidence of Adverse Events (AEs)

  Part B

  Up to 19 days

• Incidence of serious adverse events (SAEs)

  Part B

  Up to 19 days

• Incidence of death

  Part B

  Up to 19 days

• Incidence of adverse events (AEs) leading to discontinuation

  Part B

  Up to 19 days

• Incidence of clinically significant changes in clinical laboratory results: Hematology tests

  Part B

  Up to 19 days

• Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

  Part B

  Up to 19 days

• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

  Part B

  Up to 19 days

• Incidence of clinically significant changes in vital signs: Respiratory rate

  Part B

  Up to 19 days

• Incidence of clinically significant changes in vital signs: Supine blood pressure

  Part B

  Up to 19 days

• Incidence of clinically significant changes in vital signs: Heart rate

  Part B

  Up to 19 days

• Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure

  Part B

  Up to 19 days

• Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

  Part B PR interval is the time from the onset of the P wave to the start of the QRS complex

  Up to 19 days

• Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS

  Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

  Up to 19 days

• Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval

  Part B The QT interval is the time from the start of the Q wave to the end of the T wave

  Up to 19 days

• Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF

  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 wave

  Up to 19 days

• Incidence of clinically significant changes in cardiac telemetry

  Part B

  Up to 19 days

• Incidence of clinically significant changes in physical examination findings

  Part B

  Up to 19 days

Other Outcomes (14)

• Incidence of Adverse Events (AEs)

  Up to 14 days

• Incidence of serious adverse events (SAEs)

  Up to 72 days

• Incidence of death

  Up to 72 days

Study Arms (2)

Part A Furosemide

EXPERIMENTAL

Drug: Furosemide

Part B (SAD)

EXPERIMENTAL

Single Ascending Dose (SAD)

Drug: BMS-986308; Other: Placebo (for BMS-986308)

Interventions

BMS-986308 DRUG

Specified dose on specified days

Part B (SAD)

Placebo (for BMS-986308) OTHER

Specified dose on specified days

Part B (SAD)

Furosemide DRUG

Specified dose on specified days

Part A Furosemide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Heart Failure; Edema

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 21, 2021
• Study Start: April 14, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)