A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
1 other identifier
interventional
7
1 country
1
Brief Summary
The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants Participants will be admitted to the study site for 3 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Jan 2023
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
January 6, 2023
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2023
CompletedMay 25, 2023
May 1, 2023
3 months
January 6, 2023
May 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed concentration (Cmax)
Up to 45 days
Time to maximum observed concentration (Tmax)
Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 45 days
Secondary Outcomes (6)
Metabolite profiling of BMS-986435 in plasma, urine, and feces
Up to 45 days
Number of participants with adverse events (AEs)
Up to 45 days
Number of participants with clinical laboratory abnormalities
Up to 45 days
Number of participants with vital sign abnormalities
Up to 45 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 45 days
- +1 more secondary outcomes
Study Arms (1)
MYK-224
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Body mass index between 18 and 32 kg/m\^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
- Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
- Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.
You may not qualify if:
- Any acute or chronic medical illness.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Madison, Wisconsin, 53704-2526, United States
Related Links
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 17, 2023
Study Start
January 16, 2023
Primary Completion
April 8, 2023
Study Completion
April 8, 2023
Last Updated
May 25, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.htm