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Healthy ParticipantsPhase 1NCT04763226

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

A Phase 1 study testing BMS-986308 and Furosemide in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
BMS-986308 and Furosemide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteUnited States
Study dates
14 Apr 2021to 27 Feb 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Local Institution - 0001

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official 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

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.

Being tested
BMS-986308, Placebo (for BMS-986308), Furosemide
Keywords
BMS-986308, Congestive heart failure (CHF), Diuretics, Diuretic resistance, Fluid overload, Furosemide, Persistent congestion
Medical subject headings
Heart Failure, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986308Drug

    Specified dose on specified days

  • Placebo (for BMS-986308)Other

    Specified dose on specified days

  • FurosemideDrug

    Specified dose on specified days

Study groups in NCT04763226
Study groupRoleWhat they receive
Part A FurosemideExperimentalNot described
Receives: Drug: Furosemide
Part B (SAD)ExperimentalSingle Ascending Dose (SAD)
Receives: Drug: BMS-986308; Other: Placebo (for BMS-986308)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Part B

    Measured: Up to 19 days

  2. Incidence of serious adverse events (SAEs)

    Part B

    Measured: Up to 19 days

  3. Incidence of death

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

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

    Part B

    Measured: Up to 19 days

  12. 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

    Measured: Up to 19 days

  13. 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

    Measured: Up to 19 days

  14. 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

    Measured: Up to 19 days

  15. 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

    Measured: Up to 19 days

  16. Incidence of clinically significant changes in cardiac telemetry

    Part B

    Measured: Up to 19 days

  17. Incidence of clinically significant changes in physical examination findings

    Part B

    Measured: Up to 19 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start14 Apr 2021
  3. Primary completion27 Feb 2022
  4. Study completion27 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04763226
Sponsor's protocol ID
CV021-004
Status last verified
Apr 2022
First submitted
4 Feb 2021
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Soleman SI, Maya J, Levesque P, Mohammad A, Christopher L, Schumacher J, Nanduri A, Sivakumar P, Kozinn M, Costet P, Wang C, Richter J, Hawthorne D, Bui A, Rao VS, Dickerson D, Testani J, Ramirez-Valle F, Baribaud F, Murthy B, Merali S. First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986308: A Renal Outer Medullary Potassium Channel Inhibitor. Clin Pharmacol Ther. 2024 Dec;116(6):1627-1634. doi: 10.1002/cpt.3430. Epub 2024 Sep 2.

    PubMed 39219444

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986308 and Furosemide in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 19 days). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04763226, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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