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Completed

NCT Number: NCT05963932

A Study to Assess the Bioavailability and Effect of Food of BMS-986419 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986419 DR Capsule

Drug

Specified dose on specified days

BMS-986419 IR Tablet

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 15 days

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

    Time frame: Up to 15 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

    Time frame: Up to 15 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 29 days

  2. Number of participants with vital sign abnormalities

    Time frame: Up to 29 days

  3. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 29 days

  4. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 29 days

  5. Number of participants with physical examination abnormalities

    Time frame: Up to 29 days

  6. Time to attain maximum observed plasma concentration (Tmax)

    Time frame: Up to 15 days

  7. Terminal half-life (T-Half)

    Time frame: Up to 15 days

  8. Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))

    Time frame: Up to 15 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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