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Clinical Trials in the UK / NCT06481306
Recruiting Phase 1/2

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

NCT06481306 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/2
Started
2024-07-17
Last updated
2026-08-18

Condition(s) studied

Anemia, Sickle CellHealthy Volunteers

Investigational drug(s) / intervention(s)

BMS-986470PlaceboFamotidinePantoprazole

BMS-986470: Specified dose on specified days

Placebo: Specified dose on specified days

Famotidine: Specified dose on specified days

Pantoprazole: Specified dose on specified days

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of California San Diego - La Jolla La Jolla California Recruiting
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Yale-New Haven Hospital New Haven Connecticut Recruiting
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
Local Institution - 0034 Chicago Illinois Not Yet Recruiting
Local Institution - 0001 Lenexa Kansas Active Not Recruiting
Local Institution - 0064 Baltimore Maryland Not Yet Recruiting
Local Institution - 0024 Boston Massachusetts Not Yet Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Local Institution - 0030 St Louis Missouri Not Yet Recruiting
Local Institution - 0033 Greenville North Carolina Not Yet Recruiting
Local Institution - 0028 Cleveland Ohio Not Yet Recruiting
Local Institution - 0029 Philadelphia Pennsylvania Not Yet Recruiting
Thomas Jefferson University - Medicine/GI and Hepatology Philadelphia Pennsylvania Recruiting
Local Institution - 0032 Pittsburgh Pennsylvania Not Yet Recruiting
Local Institution - 0027 Greenville South Carolina Not Yet Recruiting
Inova Schar Cancer Institute Fairfax Virginia Recruiting
Virginia Commonwealth University (VCU) Medical Center Richmond Virginia Recruiting
Local Institution - 0050 Vancouver British Columbia Not Yet Recruiting
Local Institution - 0061 Créteil France Not Yet Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Marseille France Recruiting
Hôpital Universitaire Necker Enfants Malades Paris France Recruiting
CHU Strasbourg-Hautepierre Strasbourg France Recruiting
Local Institution - 0011 Milan Lombardy Not Yet Recruiting
Local Institution - 0037 Padua Italy Not Yet Recruiting
Local Institution - 0009 Verona Italy Not Yet Recruiting
University Hospitals Sussex NHS Foundation Trust East Sussex Brighton And Hove Recruiting
Local Institution - 0044 London Greater London Not Yet Recruiting
King's College Hospital London London, City of Recruiting
Local Institution - 0005 Leeds United Kingdom Not Yet Recruiting
Local Institution - 0047 London United Kingdom Not Yet Recruiting

On this site

📄 Pepcid (famotidine) drug profile → 📄 Protonix (pantoprazole) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06481306 on ClinicalTrials.gov ↗ ← All trials in the UK