NCT06481306 · Bristol-Myers Squibb
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
What this study is about
The purpose of this study is to evaluate the safety and how well patients handle the treatment, how the drug moves through the body and how the drug affects the body, pH and food effect, and preliminary effectiveness of BMS-986470 in healthy volunteers and participants with sickle cell disease.
View original scientific description
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.
Interventions
DRUG
BMS-986470
Specified dose on specified days
DRUG
Placebo
Specified dose on specified days
DRUG
Famotidine
Specified dose on specified days
DRUG
Pantoprazole
Specified dose on specified days
Primary outcome measures
Number of participants with adverse events (AEs)
Time frame: Up to 26 months
Number of participants with serious adverse events (SAEs)
Time frame: Up to 26 months
Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Time frame: Up to 26 months
Number of participants with AEs leading to discontinuation
Time frame: Up to 26 months
Number of deaths
Time frame: Up to 26 months
Proportion of participants achieving HbF ≥ 10%
Time frame: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 20%
Time frame: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 30%
Time frame: Up to 28 days after last dose
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \- Cohort A. i) 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. ii) Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. BMI = weight (kg)/ (height \[m\])\^2 as measured at screening. iii) 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. \- Cohort B. i) Participants with a documented diagnosis of Sickle Cell Disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal. ii) Participants with ≥ 4 vaso-o
Where
- Birmingham, Alabama
- La Jolla, California
- Oakland, California
- New Haven, Connecticut
- Atlanta, Georgia
- Chicago, Illinois
- Lenexa, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- Greenville, North Carolina
- Cleveland, Ohio
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations