BMS-986470 for Sickle Cell Disease

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Bristol-Myers Squibb

Must be taking: Hydroxyurea

Disqualifiers: Severe VOCs, Acute chest syndrome, others

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving regular blood transfusions, you may not be eligible to participate.

Eligibility Criteria

This trial is for healthy individuals and those with sickle cell disease. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details are not provided.

Inclusion Criteria

I have Sickle Cell Disease with a specific genotype.

My organs are functioning normally.

Cohort A: BMI of 18.0 to 32.0 kg/m^2

+4 more

Exclusion Criteria

I have had severe pain crises or lung-related complications.

Cohort B: Creatinine clearance < 60 mL/min/1.72m2

Cohort A: Any significant medical condition or condition confounding data interpretation

+4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986470 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

Regular visits (in-person)

Participant Groups

The study is testing BMS-986470's safety, how it affects the body (pharmacokinetics/dynamics), its behavior in different pH levels and after food intake, as well as its initial effectiveness in treating sickle cell disease compared to a placebo.

5Treatment groups

Experimental Treatment

Group I: Cohort B Part 2Experimental Treatment1 Intervention

Group II: Cohort B Part 1Experimental Treatment2 Interventions

Group III: Cohort A Part 3Experimental Treatment1 Intervention

Group IV: Cohort A Part 2Experimental Treatment2 Interventions

Group V: Cohort A Part 1Experimental Treatment2 Interventions