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OpenTrials
Completed

NCT Number: NCT04763226

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986308

Drug

Specified dose on specified days

Placebo (for BMS-986308)

Other

Specified dose on specified days

Furosemide

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 19 days

    Part B

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 19 days

    Part B

  3. Incidence of death

    Time frame: Up to 19 days

    Part B

  4. Incidence of adverse events (AEs) leading to discontinuation

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

  8. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

  10. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

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

    Time frame: Up to 19 days

    Part B

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

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

    Time frame: Up to 19 days

    Part B

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

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

    Time frame: 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 wave

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

    Time frame: 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 wave

  16. Incidence of clinically significant changes in cardiac telemetry

    Time frame: Up to 19 days

    Part B

  17. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 19 days

    Part B

Other outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 14 days

    Part A

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 72 days

    Part A

  3. Incidence of death

    Time frame: Up to 72 days

    Part A

  4. Incidence of adverse events (AEs) leading to discontinuation

    Time frame: Up to 72 days

    Part A

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 14 days

    Part A

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

    Time frame: Up to 14 days

    Part A

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 14 days

    Part A

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

    Time frame: Up to 3 days

    Part A

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

    Time frame: Up to 14 days

    Part A

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

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

    Time frame: Up to 14 days

    Part A

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

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

    Time frame: Up to 14 days

    Part A

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

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

    Time frame: Up to 14 days

    Part A

    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

  13. Incidence of clinically significant changes in cardiac telemetry

    Time frame: Up to 3 days

    Part A

  14. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 14 days

    Part A

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986308 in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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