Back to resultsA Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
Primary Purpose
Healthy Volunteers
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Danicamtiv
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers focused on measuring BMS-986434, MYK-491, Healthy, Biological Availability, Food Effect
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive Participants with resting heart rate ≥ 55 bpm Seasonal allergies that do not require medication at the time of the study are acceptable Exclusion Criteria: Any acute or chronic medical illness Head injury, intracranial tumor, or aneurysm within 2 years prior to screening History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
Sites / Locations
- Anaheim Clinical TrialsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Secondary Outcome Measures
Time of maximum observed plasma concentration (Tmax)
Terminal elimination half-life (T-HALF)
Apparent total body clearance (CLT/F)
Apparent volume of distribution (Vz/F)
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
Number of participants with vital sign abnormalities
Number of participants with Electrocardiogram (ECG) abnormalities
Number of participants with Physical Examination (PE) abnormalities
Number of participants with clinical laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06027437
Brief Title
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
Official Title
A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
November 9, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
BMS-986434, MYK-491, Healthy, Biological Availability, Food Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Title
Treatment B
Arm Type
Experimental
Arm Title
Treatment C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Danicamtiv
Other Intervention Name(s)
BMS-986434, MYK-491
Intervention Description
Specified dose on specified days.
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to day 16
Title
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame
Up to day 16
Title
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 day 16
Secondary Outcome Measure Information:
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to day 16
Title
Terminal elimination half-life (T-HALF)
Time Frame
Up to day 16
Title
Apparent total body clearance (CLT/F)
Time Frame
Up to day 16
Title
Apparent volume of distribution (Vz/F)
Time Frame
Up to day 16
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to day 43
Title
Number of participants with Serious Adverse Events (SAEs)
Time Frame
Up to day 43
Title
Number of participants with vital sign abnormalities
Time Frame
Up to day 16
Title
Number of participants with Electrocardiogram (ECG) abnormalities
Time Frame
Up to day 16
Title
Number of participants with Physical Examination (PE) abnormalities
Time Frame
Up to day 16
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to day 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
Participants with resting heart rate ≥ 55 bpm
Seasonal allergies that do not require medication at the time of the study are acceptable
Exclusion Criteria:
Any acute or chronic medical illness
Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site#
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina Haggag, Site 0001
Phone
714-774-7777
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
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