Actively Recruiting
A Phase 12a Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Led by Bristol-Myers Squibb · Updated on 2026-03-17
184
Participants Needed
19
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BMS-986470, a new drug, in healthy volunteers and people with sickle cell disease to study its safety, how the body processes it, how it affects blood pH and food interactions, and its early effects. This Phase 12a, randomized, double-blinded, placebo-controlled study aims to find the right dose and understand tolerability over a long period. Participants receive BMS-986470 or placebo, sometimes with famotidine, at specific doses and days across different study groups called cohorts. The trial includes multiple parts focusing on dose finding and effect evaluations. Some participants are healthy adults without childbearing potential, while others have sickle cell disease with specific genotypes and recent vaso-occlusive crises. During the study, participants are closely monitored for safety, including adverse events for up to 26 months. Researchers measure blood drug levels and hemoglobin changes, including sickle and fetal hemoglobin fractions, and markers of red blood cell breakdown. The study tracks treatment effects over weeks to months with lab tests, physical exams, and vital signs to assess the drugs impact and safety.
CONDITIONS
Brief Title
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cohort A: Healthy males and females not of childbearing potential, confirmed by medical history and hormone levels or surgical history.
- Body mass index (BMI) between 18.0 and 32.0 kg/m².
- No significant organ dysfunction or abnormal clinical findings inconsistent with target population.
- Cohort B: Diagnosed sickle cell disease with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
- At least 4 vaso-occlusive crises (VOCs) in the past 12 months or at least 2 VOCs in the past 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory values within specified ranges: hemoglobin, neutrophil count, platelet count, and reticulocyte count (adjusted if taking hydroxyurea).
You will not qualify if you...
- Cohort A: Any significant medical condition that could affect study data interpretation or pose unacceptable risk.
- Major or planned surgery (except gastrointestinal) within 12 weeks before first study intervention.
- Cohort B: Any significant acute or chronic illness, active or uncontrolled infection, or lab abnormalities posing unacceptable risk.
- More than 6 severe VOCs requiring 24+ hours hospital admission in past 12 months or any VOC requiring 24+ hours admission within 30 days before first dose.
- Acute chest syndrome episode within 6 months before first dose.
- Creatinine clearance below 60 mL/min/1.72m².
- Regularly scheduled blood or platelet transfusions, or recent transfusions within specified days before treatment start.
Research Team
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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