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
Apply to this trial

Conditions

  • Anemia, Sickle Cell
  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • BMS-986470 — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days
  • Famotidine — DRUG
    Specified dose on specified days
  • Pantoprazole — DRUG
    Specified 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

First listed
Jul 1, 2024
Start date
Jul 17, 2024
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Oct 28, 2029

Study Design

Enrollment
224 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.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (19)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Julie Kanter, Site 0008
205-975-2837
University of California San Diego - La JollaLa JollaCalifornia92037
Srila Gopal, Site 0021
858-822-6276
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Mark Walters, Site 0003
Yale-New Haven HospitalNew HavenConnecticut06510
Cecelia Calhoun, Site 0022
000-000-0000
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Fuad El Rassi, Site 0017
404-778-1350
Local Institution - 0034ChicagoIllinois60612
Site 0034
Local Institution - 0001LenexaKansas66219-
Local Institution - 0064BaltimoreMaryland21287
Site 0064
Boston Medical CenterBostonMassachusetts02118
Elizabeth Klings, Site 0016
617-638-8265
Local Institution - 0024BostonMassachusetts02114
Site 0024
Local Institution - 0030St LouisMissouri63110
Site 0030
Local Institution - 0033GreenvilleNorth Carolina27834
Site 0033
Local Institution - 0028ClevelandOhio44195
Site 0028
Local Institution - 0029PhiladelphiaPennsylvania19104
Site 0029
Thomas Jefferson University - Medicine/GI and HepatologyPhiladelphiaPennsylvania19107
Sanaa Rizk, Site 0007
000-000-0000
Local Institution - 0032PittsburghPennsylvania15213
Site 0032
Local Institution - 0027GreenvilleSouth Carolina29605
Site 0027
Inova Schar Cancer InstituteFairfaxVirginia22031
Sheinei Alan, Site 0013
571-472-4724
Virginia Commonwealth University (VCU) Medical CenterRichmondVirginia23298
Thokozeni Lipato, Site 0014
804-828-8870

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By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California San Diego - La Jolla· La Jolla, CAUCSF Benioff Children's Hospital Oakland· Oakland, CAYale-New Haven Hospital· New Haven, CTWinship Cancer Institute of Emory University· Atlanta, GALocal Institution - 0034· Chicago, IL

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