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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Diltiazem; Drug: Danicamtiv; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162222

CV028-008

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Danicamtiv, followed by itraconazole + danicamtiv

Experimental group

Treatment:

Drug: Itraconazole

Drug: Danicamtiv

Danicamtiv, followed by diltiazem + danicamtiv

Experimental group

Treatment:

Drug: Diltiazem

Drug: Danicamtiv