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To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males

NCT05816356 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-22

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

Decitabine

Oral administration of decitabine as a single dose to healthy male subjects

DRUG

Tetrahydrouridine

Oral administration of Tetrahydrouridine as a single dose to healthy male subjects

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • EpiDestiny, Inc.

    lead INDUSTRY

Principal Investigators

  • Ingela Danielsson, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-06-30
Completion
2023-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816356 on ClinicalTrials.gov