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Recruiting Phase 1, Phase 2 NCT06481306

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

Trial Parameters

Condition Anemia, Sickle Cell
Sponsor Bristol-Myers Squibb
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 184
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-17
Completion 2027-01-06
Interventions
BMS-986470PlaceboFamotidine

Brief 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 Criteria

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-occlusiv

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