A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Bristol-Myers Squibb · NCT06481306
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 224
- US sites recruiting
- 9
- Study start
- July 17, 2024
- Record last updated
- August 18, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: BMS-986470; Placebo; Famotidine; Pantoprazole
Conditions: Anemia, Sickle Cell; Healthy Volunteers
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
Cohort A
- 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.
Cohort B
- 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:
i) Hemoglobin ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females). ii) Absolute neutrophil count ≥ 1500/μL. iii) Platelet count ≥ 100 × 10\^3/μL. iv) Absolute reticulocyte count > 100 × 10\^3/μL or > 50 × 10\^3/μL if taking hydroxyurea.
Exclusion Criteria
Cohort A
- 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.
Cohort B
- 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.
Cohort A and B
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Recruiting US locations
University of Alabama at Birmingham
Birmingham, AL 35233
Site contact: Julie Kanter, Site 0008 · 205-975-2837
University of California San Diego - La Jolla
La Jolla, CA 92037
Site contact: Srila Gopal, Site 0021 · 858-822-6276
UCSF Benioff Children's Hospital Oakland
Oakland, CA 94609
Site contact: Mark Walters, Site 0003
Yale-New Haven Hospital
New Haven, CT 06510
Site contact: Cecelia Calhoun, Site 0022 · 000-000-0000
Winship Cancer Institute of Emory University
Atlanta, GA 30322
Site contact: Fuad El Rassi, Site 0017 · 404-778-1350
Boston Medical Center
Boston, MA 02118
Site contact: Elizabeth Klings, Site 0016 · 617-638-8265
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, PA 19107
Site contact: Sanaa Rizk, Site 0007 · 000-000-0000
Inova Schar Cancer Institute
Fairfax, VA 22031
Site contact: Sheinei Alan, Site 0013 · 571-472-4724
Virginia Commonwealth University (VCU) Medical Center
Richmond, VA 23298
Site contact: Thokozeni Lipato, Site 0014 · 804-828-8870
Study contacts (from the official record)
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
- First line of the email MUST contain NCT # and Site #.
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