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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963932
• Other study ID #: CN007-1001
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2023
• Est. completion date: October 17, 2023

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986419 DR Capsule
Specified dose on specified days
• BMS-986419 IR Tablet
Specified dose on specified days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to 15 days
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Up to 15 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])		Up to 15 days
Secondary	Number of participants with adverse events (AEs)		Up to 29 days
Secondary	Number of participants with vital sign abnormalities		Up to 29 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 29 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 29 days
Secondary	Number of participants with physical examination abnormalities		Up to 29 days
Secondary	Time to attain maximum observed plasma concentration (Tmax)		Up to 15 days
Secondary	Terminal half-life (T-Half)		Up to 15 days
Secondary	Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))		Up to 15 days

External Links

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