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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162222
• Other study ID #: CV028-008
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Danicamtiv
Specified dose on specified days
• Itraconazole
Specified dose on specified days
• Diltiazem
Specified dose on specified days

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to 17 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))		Up to 17 days
Primary	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	Time of maximum observed plasma concentration (Tmax)		Up to 17 days
Secondary	Concentration at 24 hours (C24)		Up to 17 days
Secondary	Apparent terminal plasma half-life (T-HALF)		Up to 17 days
Secondary	Incidence of adverse events (AEs)		Up to 28 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 28 days
Secondary	Incidence of participants with vital sign abnormalities		Up to 17 days
Secondary	Incidence of participants with electrocardiogram (ECG) abnormalities		Up to 17 days
Secondary	Incidence of participants with physical exam abnormalities		Up to 17 days
Secondary	Incidence of participants with clinical laboratory abnormalities		Up to 17 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form