A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05162222
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Danicamtiv, followed by diltiazem + danicamtiv Diltiazem - Danicamtiv, followed by itraconazole + danicamtiv Danicamtiv - Danicamtiv, followed by itraconazole + danicamtiv Itraconazole - Danicamtiv, followed by diltiazem + danicamtiv Danicamtiv -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) 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 Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) Up to 17 days
- Secondary Outcome Measures
Name Time Method 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 Time of maximum observed plasma concentration (Tmax) Up to 17 days Concentration at 24 hours (C24) 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit - Dallas
🇺🇸Dallas, Texas, United States