To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.
The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive 2000mg Epeleuton (DS102) capsules twice daily.
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Changes from baseline in P-selectin
Change in P-selectin from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in Hemoglobin
Change in hemoglobin from baseline at Week 16
Time frame: 16 Weeks
Changes from baseline in absolute reticulocyte count
Change in absolute reticulocyte count from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in E-selectin
Change in E-selectin from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in Phosphatidylserine
Change in Phosphatidlyserine from baseline to week 16.
Time frame: 16 Weeks
Changes from baseline in annualized rate of VOCs leading to a healthcare visit, and VOCs that are treated at home
Changes in annualized rate of VOCs leading to a healthcare visit, and VOCs that are treated at home from baseline to week 16
Time frame: 16 Weeks
Changes from baseline in RBC Laminin Adhesion
Changes in RBC Laminin Adhesion from baseline to week 16
Time frame: 16 Weeks
Changes from baseline in Leukocytes
Changes in Leukocytes from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Vascular Cell Adhesion Molecule 1 (VCAM-1)
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Changes in VCAM-1 from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Dense Red Blood Cells
Changes in Dense Red Blood Cells from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Osmoscan
Changes in Osmoscan from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Oxygen Point of Sickling
Changes in Oxygen Point of Sickling from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in D-dimer
Changes in D-dimer from baseline to Week 16
Time frame: 16 Weeks
Change from baseline in PROMIS Pain Interference Short Form
Change in PROMIS Pain Interference from baseline to Week 16
Time frame: 16 Weeks
Change from baseline in PROMIS Physical Activity Short Form
Change in PROMIS Physical Activity from baseline to Week 16
Time frame: 16 Weeks
Trough plasma concentrations of total and unesterified 15 HEPE
Trough plasma concentrations of total and unesterified 15 HEPE at baseline and Week 16
Time frame: 16 Weeks
Determination of exploratory biomarkers from baseline
Determination of exploratory biomarkers at baseline and Week 16
Time frame: 16 Weeks