A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants

A Phase 1, Open-label, Randomized, Parallel-group, Single Dose Study to Assess the Relative Bioavailability of a New BMS-986419 Immediate-release Tablet Formulation Compared to a Reference Enteric Capsule (Delayed-release) Formulation, and to Assess the Effect of Food on the Pharmacokinetics of Immediate-release Tablet Formulation in Healthy Adult Participants

The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986419 DR Capsule; Drug: BMS-986419 IR Tablet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
• Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and body weight ≥ 50 kg.
• A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)

Exclusion Criteria:

• Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
• History of Gilbert's syndrome.
• Women who are of childbearing potential and women who are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: BMS-986419 DR Capsule - Fasted	Drug: BMS-986419 DR Capsule; Specified dose on specified days
Experimental: Treatment B: BMS-986419 IR Tablet - Fasted	Drug: BMS-986419 IR Tablet; Specified dose on specified days
Experimental: Treatment C: BMS-986419 IR Tablet - Fed	Drug: BMS-986419 IR Tablet; Specified dose on specified days
Experimental: Treatment D: BMS-986419 Crushed IR Tablet - Fed	Drug: BMS-986419 IR Tablet; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Up to 15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to 29 days
Number of participants with vital sign abnormalities	Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 29 days
Number of participants with clinical laboratory abnormalities	Up to 29 days
Number of participants with physical examination abnormalities	Up to 29 days
Time to attain maximum observed plasma concentration (Tmax)	Up to 15 days
Terminal half-life (T-Half)	Up to 15 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))	Up to 15 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: BMS-986419; Healthy male of non-child bearing potential; Healthy women of non-child bearing potential
• Other Study ID Numbers: CN007-1001

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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-andpartners/ clinical-trials-andresearch/disclosure-commitment.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