Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT05816356
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2023-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males
Sponsor:
EpiDestiny, Inc.
Organization:
Study Overview
Official Title:
An Open Label, Randomized, Single Dose, Two Way Crossover, Bioavailability Study of a Combination Formulation of Decitabine/Tetrahydrouridine (2.5 mg/100 mg) Modified Release Capsules in Healthy, Fasting, Male Adults
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, randomized, single-dose per period, two-period, crossover study to evaluate the relative bioavailability of decitabine and tetrahydrouridine ingested as a modified-release combination formulation compared to THU and decitabine ingested as immediate-release capsules
Detailed Description:
This study builds on previous bioavailability studies in healthy volunteers of a larger combination dosage form of decitabine and tetrahydrouridine (THU) (5 mg/250 mg). The smaller combination dosage form being evaluated in this study (2.5 mg/100 mg) is intended to allow more precise weight band dosing, to hopefully further decrease the inter-individual variability in pharmacokinetics and pharmacodynamics.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: