A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2022
CompletedJanuary 13, 2023
January 1, 2023
7 months
March 22, 2022
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
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])
Up to 36 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 36 days
Secondary Outcomes (15)
Time of maximum observed plasma concentration (Tmax)
Up to 36 days
Apparent terminal plasma half-life (T-HALF)
Up to 36 days
Apparent total body clearance (CLT/F)
Up to 36 days
Number of participants with adverse events (AEs)
Up to 52 days
Number of participants with serious adverse events (SAEs)
Up to 52 days
- +10 more secondary outcomes
Study Arms (3)
Arm 1: MYK-224
EXPERIMENTALArm 2: MYK-224 + Itraconazole
EXPERIMENTALArm 3: MYK-224 + Verapamil
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any acute or chronic medical illness
- History of dizziness and/or recurrent headaches
- History of heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Dallas, Texas, 75247, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2022
First Posted
March 31, 2022
Study Start
April 21, 2022
Primary Completion
November 14, 2022
Study Completion
November 29, 2022
Last Updated
January 13, 2023
Record last verified: 2023-01