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
- Diseases
- Heart failure
- 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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Holy Cross Hospital Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Nature Coast Clinical Research Coordinator of this site? Confirm its status | Inverness | United States | Unknown status |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Research Integrity LLC Coordinator of this site? Confirm its status | Owensboro | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.