NCT07431398TerminatedPhase 1
Single-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell Disease
A Phase 1, Open-Label Study to Assess Pharmacokinetics After Single Doses of Pociredir in Participants With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 18 Feb 2026
- Start date
- 13 Dec 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Fulcrum Therapeutics
- Diseases
- Sickle cell disease
- NCT number
- NCT07431398
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
- Participants who meet all other inclusion and exclusion criteria for this study, and per Investigator's recommendation may continue crizanlizumab, and/or L-glutamine, must be on a stable dose for at least 6 months
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center, Houston | Houston | United States | Unknown status |
| Advanced Pharma - Miami | Miami | United States | Unknown status |
| Neuro-Behavioral Clinical Research | North Canton | United States | Unknown status |
| OMEGA Research Group | Orlando | United States | Unknown status |
| Sonar Clinical Research | Riverdale | United States | Unknown status |
| Worldwide Clinical Trials | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.