Lenexa, Kansas 66219

  • Healthy Participants

Purpose:

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.


Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - In good health, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations - 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 - Normal renal function at screening (and study admission) as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula - Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Women who are of childbearing potential or breastfeeding - 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 is Available At:


Original ID:

CV021-004


NCT ID:

NCT04763226


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Not yet recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

94


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Primary Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email:
Clinical.Trials@bms.com
Backup Contact:First line of the email MUST contain NCT # and Site #.

Study Dates

Start Date:April 9, 2021
Completion Date:March 26, 2022
Completion Type:Anticipated
Primary Completion Date:March 25, 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 9, 2021
First Received Date:February 4, 2021

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of adverse events (AEs) leading to discontinuation
Time Frame:Up to 72 days
Safety Issues:False
Description:Part A
Outcome Type:Secondary Outcome
Measure:Incidence of death
Time Frame:Up to 72 days
Safety Issues:False
Description:Part A
Outcome Type:Secondary Outcome
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 72 days
Safety Issues:False
Description:Part A
Outcome Type:Secondary Outcome
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 14 days
Safety Issues:False
Description:Part A
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in physical examination findings
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure: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 16 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Heart rate
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Supine blood pressure
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of adverse events (AEs) leading to discontinuation
Time Frame:Up to 85 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of death
Time Frame:Up to 85 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 85 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 27 days
Safety Issues:False
Description:Part C
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in physical examination findings
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in cardiac telemetry
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Time Frame:Up to 19 days
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B The QT interval is the time from the start of the Q wave to the end of the T wave
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B PR interval is the time from the onset of the P wave to the start of the QRS complex
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Heart rate
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Supine blood pressure
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of adverse events (AEs) leading to discontinuation
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of death
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B
Outcome Type:Primary Outcome
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 19 days
Safety Issues:False
Description:Part B

Study Interventions

Intervention Type:Drug
Name:Furosemide
Description:Specified dose on specified days
Arm Name:Part A Furosemide
Intervention Type:Other
Name:Placebo (for BMS-986308)
Description:Specified dose on specified days
Arm Name:Part B (SAD)
Intervention Type:Drug
Name:BMS-986308
Description:Specified dose on specified days
Arm Name:Part B (SAD)

Study Arms

Study Arm Type:Experimental
Arm Name:Part C (MAD)
Description:Multiple Ascending Dose (MAD)
Study Arm Type:Experimental
Arm Name:Part B (SAD)
Description:Single Ascending Dose (SAD)
Study Arm Type:Experimental
Arm Name:Part A Furosemide

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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