Actively Recruiting
Single-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell Disease
Led by Fulcrum Therapeutics · Updated on 2026-03-30
24
Participants Needed
6
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Single-dose Pharmacokinetics of Pociredir in Participants With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented Sickle Cell Disease confirmed by medical records or laboratory testing
- If female and able to have children, agrees to use two effective birth control methods or abstain from sexual activity from signing consent until 90 days after last dose
- If male, agrees to use condoms or abstain from sexual activity from signing consent until 90 days after last dose
- Total hemoglobin between 5.5 g/dL and 12 g/dL for males or 10.6 g/dL for females at screening
- Absolute neutrophil count of at least 1.5 x 10^9/L at screening
- Platelet count of at least 80 x 10^9/L at screening
- Absolute reticulocyte count greater than 100 x 10^9/L at screening
- On stable dose of crizanlizumab and/or L-glutamine for at least 6 months or not taking these medications
- Meets all other inclusion and exclusion criteria as determined by the investigator
You will not qualify if you...
- Had major surgery, serious illness, infection requiring treatment, fever lasting more than 3 days, or sickle cell complication needing hospital or emergency care within 14 days before dosing
- Has a serious medical condition other than SCD that could prevent participation or requires ongoing treatment
- Has planned elective surgery during the study period
- Uses medications that affect cytochrome P450 3A4, P-glycoprotein, or related proteins within 14 days before dosing or expects to need them during the study
- Participated in another investigational drug study within 30 days or 5 half-lives before dosing
- For Fed Cohort: has special dietary restrictions or cannot consume standard meals as required
- Other protocol-specific criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Advanced Pharma - Miami
Miami, Florida, United States, 33147
Actively Recruiting
2
Omega Research Group
Orlando, Florida, United States, 32808
Actively Recruiting
3
Sonar Clinical Research
Riverdale, Georgia, United States, 30274
Actively Recruiting
4
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
5
University of Texas Health Science Center Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
6
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Actively Recruiting
Research Team
C
Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here