Study of BMS-986470 for Sickle Cell Disease and in Healthy Volunteers
This study is testing a drug called BMS-986470 in healthy volunteers and people with sickle cell disease. Researchers want to see if BMS-986470 is safe, how your body handles it (pharmacokinetics), what effects it has on your body (pharmacodynamics), and if it helps with sickle cell disease. They will also look at how food and stomach acid (pH) affect the drug. You could be eligible if you are 18 or older. The main way success is measured in this study is by tracking any side effects (adverse events) that participants experience over a period of up to 26 months. The current recruitment status for this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 224 participants. It involves giving participants either BMS-986470, a placebo (an inactive substance), Famotidine, or Pantoprazole.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 26 months to monitor for adverse events.
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NCT06481306
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Recruiting
PHASE1Ages 18+InterventionalTreatmentBristol-Myers Squibb
~224 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:BMS-986470PlaceboFamotidinePantoprazole
At a glance
Recruiting sites
14 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to 26 months
+7 more outcomes measured
Conditions
Where it's being run
32 sites across 22 statesFrance4
Pennsylvania3
California2
Massachusetts2
Virginia2
Italy2
United Kingdom2
Alabama1
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations. Females not of childbearing potential must have been amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU/L or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2 as measured at screening.
No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population.
Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
For Cohort B Part 1 only: Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months. For Cohort B Part 2 only: Participants with ≥ 2 VOCs and ≤ 15 VOCs within the previous 12 months.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants must have the following laboratory values:
Exclusion
Any significant medical condition or any condition that confounds the ability to interpret data from the study.
Participant has any condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk if the participant was to participate in the study.
Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.
Participants with any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
For Cohort B Part 1 only: participants with more than 6 severe VOCs defined as VOCs requiring ≥ 24 hours of hospital admission within 12 months prior to the first dose of study intervention.
For Cohort B Part 1 only: participants with any episode of acute chest syndrome within the last 6 months prior to the first dose of study intervention.
Creatinine clearance (CrCl) \< 60 mL/min/1.72m2 using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.
Participant is receiving regularly scheduled RBC or platelet transfusions or has received a RBC transfusion within 28 days and a platelet transfusion within 14 days prior to starting treatment with BMS-986470.
What this trial measures
- Number of participants with adverse events (AEs)Up to 26 months
- Number of participants with serious adverse events (SAEs)Up to 26 months
- Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteriaUp to 26 months
- Number of participants with AEs leading to discontinuationUp to 26 months
- Number of deathsUp to 26 months
- Proportion of participants achieving HbF ≥ 10%Up to 28 days after last dose
- Proportion of participants achieving HbF ≥ 20%Up to 28 days after last dose
- Proportion of participants achieving HbF ≥ 30%Up to 28 days after last dose