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RecruitingAccepts healthy volunteersPhase 1/Phase 2

A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease

Bristol-Myers Squibb · NCT06481306

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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 #.
A Study to Evaluate BMS-986470 in Healthy Volunteers and… (NCT06481306) | Bored Studies