Ascorbate in Myelodysplastic Syndrome
NCT07283900 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2026-03-16
Summary
This is an open-label, phase II clinical trial with safety run-in evaluating the safety, tolerability, and efficacy of IV HDA in combination with azacitidine for participants with MDS.
Conditions
Interventions
- DRUG
-
High-dose ascorbate
Ascorbate, or vitamin C, is a water-soluble vitamin with antioxidant properties that also functions as a cofactor for several enzymatic reactions, including collagen synthesis and the activity of dioxygenase enzymes involved in DNA and histone demethylation
- DRUG
-
Azacitidine is a pyrimidine nucleoside analog of cytidine that incorporates into RNA and DNA, inhibiting DNA methyltransferase and leading to global DNA hypomethylation
Sponsors & Collaborators
-
Prajwal Dhakal
lead OTHER
Principal Investigators
-
Prajwal Dhakal, MD · University of Iowa
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-11
- Primary Completion
- 2028-05-01
- Completion
- 2029-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study
NCT01326845 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects
NCT02807909 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
NCT03291288 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
NCT02568397 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
NCT02224053 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940
NCT00689780 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
NCT04237597 ·Status: COMPLETED ·Phase: PHASE1
-
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
NCT05994807 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
NCT02947139 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
NCT01364987 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
NCT07213310 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study of Colchicine and Azithromycin
NCT00983294 ·Status: COMPLETED ·Phase: PHASE1
-
Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.
NCT02983890 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173
NCT02217839 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study Between Colchicine and Ketoconazole
NCT00983216 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study: ASP2151 and Midazolam
NCT02403635 ·Status: COMPLETED ·Phase: PHASE1
-
The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
NCT05321732 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 1 Study to Assess Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered to Healthy Volunteers
NCT01933997 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users
NCT03200080 ·Status: TERMINATED ·Phase: PHASE1
-
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers
NCT05009368 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers
NCT02952755 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study in Healthy Adult Volunteers
NCT02275988 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
NCT00983931 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022)
NCT07232589 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects
NCT04793295 ·Status: COMPLETED ·Phase: PHASE1