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NCT05952089CompletedPhase 1

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

An Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of Danicamtiv on the Pharmacokinetics of Midazolam in Patients With Stable Heart Failure With Reduced Ejection Fraction

Source: ClinicalTrials.gov · Last updated 4 Apr 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
13 (actual)
First submitted
11 Jul 2023
Start date
17 Aug 2023
Primary completion date
15 Mar 2024
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05952089

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 13
  • From 17 Aug 2023 to the primary completion date, 15 Mar 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Lab values

  • 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 \[sMDRD\].

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sinai Hospital of Baltimore
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Holy Cross Hospital
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesUnknown status
Nature Coast Clinical Research
Coordinator of this site? Confirm its status
InvernessUnited StatesUnknown status
Jacksonville Center for Clinical Research
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Research Integrity LLC
Coordinator of this site? Confirm its status
OwensboroUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.