A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Randomized, 2-Period Crossover Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose Pharmacokinetics of Danicamtiv in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Danicamtiv
* Drug: Itraconazole
* Drug: Diltiazem


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit Normal ECG at the Screening Visit Normal renal function at Screening Exclusion Criteria: History of ventricular arrhythmias History of heart disease or conduction disorders History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration) Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danicamtiv, followed by itraconazole + danicamtiv<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: Danicamtiv, followed by diltiazem + danicamtiv<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>Drug: Diltiazem<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Danicamtiv, Itraconazole, Diltiazem, BMS-986434, CYP3A4