Single-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell Disease

NCT07431398 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 6058-CLP-104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief Summary

This clinical trial is a study to evaluate the pharmacokinetics of the tablet formulation Pociredir in fasted and fed state participants with Sickle Cell Disease (SCD).

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Hemoglobin subunit beta; fetal hemoglobin; Pharmacokinetics; Pociredir; FTX-6058; Tablet Pharmacokinetics Study; Anemia, Sickle Cell; Hematologic diseases; Small Molecule

Outcome Measures

Primary Outcomes (10)

• Plasma concentration of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Maximum plasma concentration (Cmax) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24)) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC(0-tlast)) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Area under the plasma concentration-time curve from time 0, extrapolated to infinity (AUC(0-inf)), of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Time to maximum plasma concentration (Tmax) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Terminal disposition rate constant (λz) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Terminal half-life (t1/2) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Apparent volume of distribution during the terminal phase (Vz/F) of pociredir under fasted and fed conditions

  Day 1 through Day 4

• Apparent clearance (CL/F) of pociredir under fasted and fed conditions

  Day 1 through Day 4

Secondary Outcomes (13)

• Number of participants with treatment emergent adverse events (TEAEs) under fasted and fed conditions

  Up to Day 11

• Number of participants with clinically significant changes in safety assessments under fasted and fed conditions

  Up to Day 11

• Number of participants with clinically significant findings in clinical laboratory evaluations, vital signs, electrocardiogram (ECGs) and physical examination

  Up to Day 11

• Plasma concentration of pociredir under fasted and fed conditions compared to healthy participants

  Day 1 through Day 4

• Cmax of pociredir under fasted and fed conditions compared to healthy participants

  Day 1 through Day 4

Study Arms (2)

Fasted Cohort

EXPERIMENTAL

Pociredir single dose tablet formulation under fasted conditions.

Drug: Pociredir

Fed Cohort

EXPERIMENTAL

Pociredir single dose tablet formulation under fed conditions (after a high-fat breakfast).

Drug: Pociredir

Interventions

Pociredir DRUG

Pociredir tablet formulation

Fasted Cohort; Fed Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented SCD at the time of screening, as confirmed through review of medical records or high-performance liquid chromatography (HPLC)/electrophoresis.
• Participant, who if female and of childbearing potential, agrees to use 2 effective methods of contraception, one which must be highly effective, or practice abstinence starting at the time of the ICF signing to 90 days after the last dose of study drug, and, who if male, agrees to use condoms or practice abstinence from the time of ICF signing to 90 days after the last dose of study drug.
• Total Hb ≥ 5.5 grams/deciliter (g/dL) and ≤ 12 g/dL (males) or ≤ 10.6 g/dL (females) at screening
• Participant must meet all of the following laboratory values at screening:
• Absolute neutrophil count ≥ 1.5 × 10\^9/L (cells/liter)
• Platelets ≥ 80 × 10\^9/L
• Absolute reticulocyte count \> 100 × 10\^9/L

You may not qualify if:

• Participant has had any of the following in the 14 days prior to dosing: major surgery, serious illness, infection (clinically significant bacterial, fungal, parasitic or viral infection which requires therapy), fever not resolved within 3 days and requiring treatment, or sickle cell complication requiring care from a medical provider in a hospital or emergency care setting.
• Participant has a serious medical condition other than SCD that, in the opinion of the Investigator, would preclude them from participating in the study, or which is unresolved or requiring ongoing treatment.
• Elective surgery planned for the time period of the study.
• Use of any medications that induce or inhibit cytochrome P450 (CYP) 3A4, inhibit P-glycoprotein, breast cancer resistance protein, or multidrug and toxin extrusion protein 2-K, or are substrates of CYP2B6 within 14 days prior to first dose of study drug or anticipated need for any of these medications during the study.
• Participation in any other study with an investigational agent within the past 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
• For Fed Cohort Only: Participant has special dietary restrictions or inability to consume standard meals as required in the study.
• Note: Other protocol specified criteria may apply.

Sponsors & Collaborators

• Fulcrum Therapeutics: lead

Study Sites (6)

Advanced Pharma - Miami

Miami, Florida, 33147, United States

RECRUITING

Omega Research Group

Orlando, Florida, 32808, United States

RECRUITING

Sonar Clinical Research

Riverdale, Georgia, 30274, United States

RECRUITING

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

RECRUITING

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; beta-Thalassemia; Hematologic Diseases

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia

Central Study Contacts

Call Center

CONTACT

clinicaltrials@fulcrumtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: December 13, 2025
• Primary Completion: May 31, 2026
• Study Completion: June 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)