Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pociredir

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Fulcrum Therapeutics
Study ID
NCT05169580
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Pociredir in participants with sickle cell disease.

Key Dates

Start date
Dec 13, 2021
Status verified
Feb 2026
Primary completion
Jan 20, 2026
Completion
Jan 20, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pociredir oral capsule(s) in Sickle Cell participants
    Cohort 1 will receive 6 mg of Pociredir by mouth once daily. Cohort 2 will be dosed at 2 mg once daily by mouth, and cohort 3 will be dosed at 12 mg once daily by mouth. The Sponsor will reinitiate enrolment in the 3rd cohort (12 mg cohort) with the updated inclusion and exclusion criteria. Based on review of available safety and biomarker data and with the recommendation of the DMC, a subsequent 4th cohort of 20 mg and potentially a 5th cohort of 30 mg may be initiated. A total of seven cohorts may be included. Following the first cohort, doses for all subsequent cohorts will be determined following DMC review of the safety and pharmacokinetic data observed in participants from the prior and ongoing cohorts. Alternate dosing schedules may be evaluated in some of the cohorts.

Primary Outcome Measure

Treatment-Emergent Adverse Events [ Time Frame: Up to approximately 16 weeks of monitoring ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical Sciences (UAMS)Little RockArkansas72205-
University of California, Los AngelesLos AngelesCalifornia90095-
Sonar Research CenterAtlantaGeorgia30315-
University of Illinois ChicagoChicagoIllinois60612-
Our Lady of the Lake HospitalBaton RougeLouisiana70808-
Boston Medical CenterBostonMassachusetts02118-
Queens Hospital Cancer CenterJamaicaNew York11432-
Jacobi Medical CenterThe BronxNew York10461-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Eastern Carolina UniversityGreenvilleNorth Carolina27834-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
University of Texas HoustonHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Little Rock, AR

By condition
Sickle cell disease
By research site
University of Arkansas for Medical Sciences (UAMS)· Little Rock, ARUniversity of California, Los Angeles· Los Angeles, CASonar Research Center· Atlanta, GAUniversity of Illinois Chicago· Chicago, ILOur Lady of the Lake Hospital· Baton Rouge, LABoston Medical Center· Boston, MA

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