A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06481306
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Anemia, Sickle Cell
- Healthy Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- BMS-986470 — DRUGSpecified dose on specified days
- Placebo — DRUGSpecified dose on specified days
- Famotidine — DRUGSpecified dose on specified days
Study Details
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.
Key Dates
- Start date
- Jul 17, 2024
- Status verified
- Mar 2026
- Primary completion
- Jan 6, 2027
- Completion
- Nov 16, 2027
Study Design
- Enrollment
- 184 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort A Part 1
- Experimental: Cohort A Part 2
- Experimental: Cohort A Part 3
- Experimental: Cohort B Part 1
- Experimental: Cohort B Part 2
Primary Outcome Measure
Number of participants with adverse events (AEs) [ Time Frame: Up to 26 months ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Julie Kanter, Site 0008 205-975-2837 |
| University of California San Diego - La Jolla | La Jolla | California | 92037 | Srila Gopal, Site 0021 858-822-6276 |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | Mark Walters, Site 0003 |
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | Cecelia Calhoun, Site 0022 000-000-0000 |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Fuad El Rassi, Site 0017 404-778-1350 |
| Local Institution - 0034 | Chicago | Illinois | 60612 | Site 0034 |
| Local Institution - 0001 | Lenexa | Kansas | 66219 | - |
| Boston Medical Center | Boston | Massachusetts | 02118 | Elizabeth Klings, Site 0016 617-638-8265 |
| Local Institution - 0024 | Boston | Massachusetts | 02114 | Site 0024 |
| Thomas Jefferson University - Medicine/GI and Hepatology | Philadelphia | Pennsylvania | 19107 | Sanaa Rizk, Site 0007 000-000-0000 |
| Local Institution - 0032 | Pittsburgh | Pennsylvania | 15213 | Site 0032 |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Sheinei Alan, Site 0013 571-472-4724 |
| Virginia Commonwealth University (VCU) Medical Center | Richmond | Virginia | 23298 | Thokozeni Lipato, Site 0014 612-655-2886 |
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