Trials / Active Not Recruiting
Active Not RecruitingNCT05861453
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
An Open-label Mechanistic Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Orally Administered Epeleuton in Patients With Sickle Cell Disease
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Afimmune · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.
Detailed description
The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epeleuton | Participants will receive 2000mg Epeleuton (DS102) capsules twice daily. |
Timeline
- Start date
- 2024-01-10
- Primary completion
- 2026-02-01
- Completion
- 2026-03-01
- First posted
- 2023-05-16
- Last updated
- 2025-10-27
Locations
18 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05861453. Inclusion in this directory is not an endorsement.