Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2024
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
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2025
CompletedMarch 14, 2025
March 1, 2025
6 months
August 27, 2024
March 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to 105 days
Secondary Outcomes (9)
Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]
Up to 105 days
Time of maximum observed concentration [Tmax]
Up to 105 days
Apparent terminal half-life [T-HALF]
Up to 105 days
Incidence of adverse events (AEs)
Up to approximately 5 months
Incidence of serious adverse events (SAEs)
Up to approximately 5 months
- +4 more secondary outcomes
Study Arms (3)
Treatment A: BMS-986435 Reference Dose 1
ACTIVE COMPARATORTreatment B: BMS-986435 Test Dose 1
EXPERIMENTALTreatment C: BMS-986435 Test Dose 2
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
You may not qualify if:
- Any acute or chronic medical illness.
- History of heart disease.
- Prior exposure to BMS-986435.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
San Antonio, Texas, 78209, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
September 3, 2024
Primary Completion
February 19, 2025
Study Completion
February 19, 2025
Last Updated
March 14, 2025
Record last verified: 2025-03
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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html