Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

March 12, 2025 updated by: Bristol-Myers Squibb

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

The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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
      • San Antonio, Texas, United States, 78209
        • 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any acute or chronic medical illness.
  • History of heart disease.
  • Prior exposure to BMS-986435.
  • 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment A: BMS-986435 Reference Dose 1
Drug: BMS-986435
Specified dose on specified days
Experimental: Treatment B: BMS-986435 Test Dose 1
Drug: BMS-986435
Specified dose on specified days
Experimental: Treatment C: BMS-986435 Test Dose 2
Drug: BMS-986435
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 105 days
Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time Frame: Up to 105 days
Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame: Up to 105 days
Up to 105 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]
Time Frame: Up to 105 days
Up to 105 days
Time of maximum observed concentration [Tmax]
Time Frame: Up to 105 days
Up to 105 days
Apparent terminal half-life [T-HALF]
Time Frame: Up to 105 days
Up to 105 days
Incidence of adverse events (AEs)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Incidence of serious adverse events (SAEs)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Incidence of participants with vital sign abnormalities
Time Frame: Up to 105 days
Up to 105 days
Incidence of participants with physical examinations abnormalities
Time Frame: Up to 105 days
Up to 105 days
Incidence of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 105 days
Up to 105 days
Incidence of participants with clinical laboratory abnormalities
Time Frame: Up to 105 days
Up to 105 days

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, 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)

September 3, 2024

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV029-1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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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