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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05162222
Enrollment
30
Registered
2021-12-17
Start date
2021-12-15
Completion date
2022-07-08
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Danicamtiv, Itraconazole, Diltiazem, BMS-986434, CYP3A4

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.

Interventions

DRUGDanicamtiv

Specified dose on specified days

DRUGItraconazole

Specified dose on specified days

DRUGDiltiazem

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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/

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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 abnormalitiesUp to 17 days
Time of maximum observed plasma concentration (Tmax)Up to 17 days
Incidence of participants with physical exam abnormalitiesUp to 17 days
Incidence of participants with clinical laboratory abnormalitiesUp to 17 days
Incidence of participants with electrocardiogram (ECG) abnormalitiesUp to 17 days
Concentration at 24 hours (C24)Up to 17 days
Apparent terminal plasma half-life (T-HALF)Up to 17 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026