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The purpose of this study is to evaluate the effects of co-administration of itraconazole or diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danicamtiv, followed by itraconazole + danicamtiv | Experimental |
| |
| Danicamtiv, followed by diltiazem + danicamtiv | 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 17 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) | Up to 17 days | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) | Up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 17 days | |
| Concentration at 24 hours (C24) | Up to 17 days | |
| Apparent terminal plasma half-life (T-HALF) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit - Dallas | Dallas | Texas | 75247-4968 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Itraconazole | Drug | Specified dose on specified days |
|
| Diltiazem | Drug | Specified dose on specified days |
|
| Up to 17 days |
| Incidence of adverse events (AEs) | Up to 28 days |
| Incidence of serious adverse events (SAEs) | Up to 28 days |
| Incidence of participants with vital sign abnormalities | Up to 17 days |
| Incidence of participants with electrocardiogram (ECG) abnormalities | Up to 17 days |
| Incidence of participants with physical exam abnormalities | Up to 17 days |
| Incidence of participants with clinical laboratory abnormalities | Up to 17 days |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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