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CompletedNCT05952089Updated Apr 4, 2024

A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure

A Phase 1 interventional study of Danicamtiv and Midazolam in Heart Failure With Reduced Ejection Fraction, sponsored by Bristol-Myers Squibb. Completed at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is assess the effect of danicamtiv, as an inducer on the drug levels of midazolam in participants with heart failure with reduced ejection fraction (HFrEF).

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction

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Keywords

  • HFrEF
  • Danicamtiv
  • BMS-986434
  • MYK-491
  • Midazolam
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 13 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ambulatory participants with stable HFrEF due to any etiology.
  • Body mass index (BMI) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive.
  • Documented left ventricular ejection fraction (LVEF) 15% to 45% (on 2 occasions), including at least once during Screening and confirmed by the Echo Core Laboratory (the absolute difference between the 2 LVEF values qualifying the participant should be \< 12%).
  • Participant receiving chronic medication for the treatment of heart failure reflecting current guidelines, including at least one of the following, unless not tolerated or contraindicated:β-blocker, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or angiotensin receptor neprilysin inhibitor. Such treatments should have been given at stable doses for at least ≥ 2 weeks prior to screening with no plan to modify treatments during the study.
  • Sinus rhythm or stable atrial or ventricular pacing or persistent atrial fibrillation that is adequately rate-controlled to allow pharmacodynamic (PD) assessments by Transthoracic echocardiogram (TTE). NOTE: Participants with implanted cardioverter defibrillator (ICD), pacing, or cardiac resynchronization therapy are eligible provided device programming is unchanged starting 2 months prior to and throughout the dosing period.
  • Adequate acoustic windows, determined by the Echo Core Laboratory, to enable accurate TTE assessments.

Exclusion criteria

Exclusion Criteria:

  • Presence of disqualifying cardiac rhythms that would preclude echocardiographic assessments, as determined by the Investigator, including: (a) rapid, inadequately rate controlled atrial fibrillation or (b) frequent premature ventricular contractions that might interfere with reliable echocardiographic measurements of left ventricular function.
  • History of bronchospasm, or history of respiratory depression or arrest, airway obstruction, oxygen desaturation, or apnea.
  • History of allergy to midazolam, other benzodiazepines, danicamtiv, related compounds, or excipients in the formulations.
  • Severe renal insufficiency (defined as current estimated glomerular filtration rate [eGFR] \< 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease equation [sMDRD].
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Danicamtiv + Midazolam

    Drug: Danicamtiv · Drug: Midazolam

Interventions

  • DrugDanicamtiv

    Specified dose on specified days

    Also known as: BMS-986434, MYK-491

  • DrugMidazolam

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 12

  2. Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])

    Time frame: Up to Day 12

  3. Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])

    Time frame: Up to Day 12

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 12

  2. Terminal elimination half-life (T-HALF)

    Time frame: Up to Day 12

  3. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to Day 12

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 12

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 12

  6. Number of participants with physical examination abnormalities

    Time frame: Up to Day 12

  7. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 11

07

Study locations

5 sites
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Nature Coast Clinical Research
    Inverness, Florida 34452, United States
  • Jacksonville Center For Clinical Research
    Jacksonville, Florida 32216, United States
  • Research Integrity LLC
    Owensboro, Kentucky 42303, United States
  • Sinai Hospital Of Baltimore
    Baltimore, Maryland 21215, United States
08

References and documents

Individual participant data

Plan to share: No — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05952089
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jul 19, 2023
Start date
Aug 17, 2023
Primary completion
Mar 15, 2024
Completion
Mar 19, 2024
Last update
Apr 4, 2024

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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