A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06715683
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2, Sequence 2 BMS-986278 Batched method, Dose A - Part 2, Sequence 2 BMS-986278 Continuous method - Part 1, Sequence 1 BMS-986278 Batched method, Dose A - Part 1, Sequence 1 BMS-986278 Batched method, Dose B - Part 1, Sequence 2 BMS-986278 Batched method, Dose A - Part 1, Sequence 2 BMS-986278 Batched method, Dose B - Part 2, Sequence 1 BMS-986278 Batched method, Dose A - Part 2, Sequence 1 BMS-986278 Continuous method -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Up to Day 24 Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T)) Up to Day 24 Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF)) Up to Day 24
- Secondary Outcome Measures
Name Time Method Terminal Phase Half-life (T-HALF) Up to Day 24 Apparent Total Body Clearance (CLT/F) Up to Day 24 Apparent Volume of Distribution (Vz/F) Up to Day 24 Number of Participants With Adverse Events (AEs) Up to 28 Days Post-discontinuation of Study Intervention Number of Participants With Clinical Laboratory Abnormalities Up to Day 25 Number of Participants With Vital Sign Abnormalities Up to Day 25 Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities Up to Day 25 Time of Maximum Observed Plasma Concentration (Tmax) Up to Day 24
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does BMS-986278's bioavailability in NCT06715683 compare to PD-1/CTLA-4 inhibitors like Opdivo in healthy volunteers?
What pharmacokinetic parameters (AUC, Cmax) differentiate BMS-986278 batched vs. continuous formulations in NCT06715683?
Are there biomarkers predicting inter-individual variability in BMS-986278 absorption among healthy participants?
What adverse event profiles emerge from BMS-986278 dose escalation in NCT06715683 compared to standard-of-care immunotherapies?
How does BMS-986278's formulation strategy align with Bristol-Myers Squibb's pipeline for next-generation checkpoint inhibitors?
Trial Locations
- Locations (1)
Anaheim Clinical Trials (ACT)
🇺🇸Anaheim, California, United States