A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

January 12, 2023 updated by: Bristol-Myers Squibb

An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants

The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index between 18 and 30 kg/m^2, inclusive
  • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
  • Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
  • Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing

Exclusion Criteria:

  • Any acute or chronic medical illness
  • History of dizziness and/or recurrent headaches
  • History of heart disease

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: MYK-224
Drug: MYK-224
Specified dose on specified days
Other Names:
  • BMS-986435
Experimental: Arm 2: MYK-224 + Itraconazole
Drug: MYK-224
Specified dose on specified days
Other Names:
  • BMS-986435
Drug: Itraconazole
Specified dose on specified days
Experimental: Arm 3: MYK-224 + Verapamil
Drug: MYK-224
Specified dose on specified days
Other Names:
  • BMS-986435
Drug: Verapamil
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 36 days
Up to 36 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 36 days
Up to 36 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 36 days
Up to 36 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 36 days
Up to 36 days
Apparent terminal plasma half-life (T-HALF)
Time Frame: Up to 36 days
Up to 36 days
Apparent total body clearance (CLT/F)
Time Frame: Up to 36 days
Up to 36 days
Number of participants with adverse events (AEs)
Time Frame: Up to 52 days
Up to 52 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 52 days
Up to 52 days
Number of participants with adverse events leading to discontinuation
Time Frame: Up to 52 days
Up to 52 days
Number of participants with vital sign abnormalities
Time Frame: Up to 52 days
Up to 52 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 52 days
Up to 52 days
Measurement of left ventricular ejection fraction (LVEF)
Time Frame: Up to 52 days
Up to 52 days
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Time Frame: Up to 52 days
Up to 52 days
Measurement of left ventricular fractional shortening (LVFS)
Time Frame: Up to 52 days
Up to 52 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Time Frame: Up to 52 days
Up to 52 days
Measurement of left ventricle stroke volume (LVSV)
Time Frame: Up to 52 days
Up to 52 days
Number of participants with physical exam abnormalities
Time Frame: Up to 52 days
Up to 52 days
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 52 days
Up to 52 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 29, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV029-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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