Clinical trial NCT05963932: A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986419
Healthy male of non-child bearing potential
Healthy women of non-child bearing potential
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 15 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 29 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 29 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 29 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 29 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 29 days
measure: Time to attain maximum observed plasma concentration (Tmax)
timeFrame: Up to 15 days
measure: Terminal half-life (T-Half)
timeFrame: Up to 15 days
measure: Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: