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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danicamtiv + Midazolam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicamtiv | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 12 | |
| Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF]) | 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]) | Up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to Day 12 | |
| Terminal elimination half-life (T-HALF) | Up to Day 12 | |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States | ||
| Nature Coast Clinical Research |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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
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| Midazolam | Drug | Specified dose on specified days |
|
| Up to Day 12 |
| Number of participants with vital sign abnormalities | Up to Day 12 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 12 |
| Number of participants with physical examination abnormalities | Up to Day 12 |
| Number of participants with clinical laboratory abnormalities | Up to Day 11 |
| Inverness |
| Florida |
| 34452 |
| United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | United States |
| Research Integrity LLC | Owensboro | Kentucky | 42303 | United States |
| Sinai Hospital Of Baltimore | Baltimore | Maryland | 21215 | United States |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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