Clinical trial NCT06715683: A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants
Official title: An Open-label, Randomized, 2-Part, 4-Period, 2-Sequence, Fully Replicated Crossover Study to Assess the Comparative Bioavailability of BMS-986278 To-be-marketed Formulation Compared to the Phase 3 Clinical Trial Formulation in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Comparative Bioavailability
BMS-986278
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator.
* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive.
* Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion Criteria:

* Any significant acute or chronic medical illness as determined by the investigator.
* Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable).
* Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention \[uncomplicated appendectomy and hernia repair are acceptable\]).
* History of known risk of bleeding.
* Inability to tolerate oral medication.
* Individuals (only females) who are of childbearing potential.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 24
measure: Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))
timeFrame: Up to Day 24
measure: Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))
timeFrame: Up to Day 24
Secondary outcomes:
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to Day 24
measure: Terminal Phase Half-life (T-HALF)
timeFrame: Up to Day 24
measure: Apparent Total Body Clearance (CLT/F)
timeFrame: Up to Day 24
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Up to Day 24
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 28 Days Post-discontinuation of Study Intervention
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to Day 25
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Up to Day 25
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 25
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials (ACT)
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: