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

NCT05963932 | Completed Phase 1 FDA Drug

• 1 other identifier: CN007-1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

BMS-986419; Healthy male of non-child bearing potential; Healthy women of non-child bearing potential

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (4)

Treatment A: BMS-986419 DR Capsule - Fasted

EXPERIMENTAL

Drug: BMS-986419 DR Capsule

Treatment B: BMS-986419 IR Tablet - Fasted

EXPERIMENTAL

Drug: BMS-986419 IR Tablet

Treatment C: BMS-986419 IR Tablet - Fed

EXPERIMENTAL

Drug: BMS-986419 IR Tablet

Treatment D: BMS-986419 Crushed IR Tablet - Fed

EXPERIMENTAL

Drug: BMS-986419 IR Tablet

Interventions

BMS-986419 DR Capsule DRUG

Specified dose on specified days

Treatment A: BMS-986419 DR Capsule - Fasted

BMS-986419 IR Tablet DRUG

Specified dose on specified days

Treatment B: BMS-986419 IR Tablet - Fasted; Treatment C: BMS-986419 IR Tablet - Fed; Treatment D: BMS-986419 Crushed IR Tablet - Fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 27, 2023
• Study Start: August 8, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)