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A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure - Trial NCT05952089

Access comprehensive clinical trial information for NCT05952089 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bristol-Myers Squibb and is currently Not yet recruiting. The study focuses on Heart Failure With Reduced Ejection Fraction. Target enrollment is 16 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05952089
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05952089
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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

Study Focus

Danicamtiv

Interventional

drug

Sponsor & Location

Bristol-Myers Squibb

Timeline & Enrollment

Phase 1

Jul 17, 2023

Feb 28, 2024

16 participants

Primary Outcome

Maximum observed plasma concentration (Cmax),Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF]),Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])

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).

ICD-10 Classifications

Heart failure
Congestive heart failure
Heart failure, unspecified
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

ClinicalTrials.gov

NCT05952089

Non-Device Trial