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
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).
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 →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.
Exclusion Criteria:
Drug: Danicamtiv · Drug: Midazolam
Specified dose on specified days
Also known as: BMS-986434, MYK-491
Specified dose on specified days
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 12
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to Day 12
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
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 12
Terminal elimination half-life (T-HALF)
Time frame: Up to Day 12
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 12
Number of participants with vital sign abnormalities
Time frame: Up to Day 12
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 12
Number of participants with physical examination abnormalities
Time frame: Up to Day 12
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 11
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
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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