A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Ninetedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants
- Conditions
- Healthy Participants
- Registration Number
- NCT06568458
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria:<br><br> - Participants must be healthy males and females (INOCBP)<br><br> - Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2,<br> inclusive.<br><br> - Participant must have Body weight = 50 kg<br><br>Exclusion Criteria:<br><br> - Participant must not have current or recent GI disease<br><br> - Participant with evidence of organ dysfunction or any clinically significant<br> deviation, as determined by investigator, from normal in physical examination, vital<br> signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent<br> with the target population.<br><br> - Participant with prior exposure to BMS-986278 and exposure of any investigational<br> drug or placebo within 4 weeks of study intervention administration.<br><br> - Other protocol-defined Inclusion/Exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax);Area under the plasma concentration-time curve within a dosing interval AUC(TAU);Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T);Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
- Secondary Outcome Measures
Name Time Method Number of participants with non-serious AEs (Adverse events);Number of participants with Serious AEs;Number of participants with AEs leading to discontinuation;Number of participants with Physical examination abnormalities;Number of participants with vital sign abnormalities;Number of participants with 12-lead electrocardiogram (ECG) abnormalities;Number of participants with clinical laboratory abnormalities;Time of maximum observed plasma concentration (Tmax);Apparent terminal phase half-life (T-HALF);Apparent total body clearance (CLT/F);Apparent volume of distribution of terminal phase (Vz/F)