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

Completed · Phase 1

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

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).

Key facts

Study ID

NCT05952089

Run by

Bristol-Myers Squibb

People needed

13

Starts

2023-08-17

Expected to finish

2024-03-19

Last updated by the study team

2024-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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].

Where it is running

• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Research Integrity LLC — Owensboro, Kentucky, United States
• Sinai Hospital Of Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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