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HealthyPhase 1NCT05816356

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

A Phase 1 study testing Decitabine and Tetrahydrouridine in people with Healthy, run by EpiDestiny, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Decitabine and Tetrahydrouridine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
24 Mar 2023to 10 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related procedures being performed and be able to adhere to restrictions and examination schedules.
  • Must be able to communicate with the Investigator and understand and comply with the requirements of the study.
  • Healthy male volunteers from any race between 18 to 50 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.
  • Must have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 and 100 kg (~132 to 220 lb), inclusive, at screening.
  • Subject's clinical laboratory test results have no clinically significant findings, in the opinion of the Investigator.
  • Vital signs including systolic and diastolic blood pressure, heart rate, and temperature will be assessed in the supine position after the subject has rested for at least 5 minutes. At screening, the potential subject must have a body temperature of ≤37.7°C, with systolic blood pressure between 90 and 140 mmHg (inclusive), diastolic blood pressure between 60 and 90 mmHg (inclusive), and heart rate between 40 and 100 bpm (inclusive). Vital signs criteria at each check-in and predose measurements will be at the Investigator's discretion. Out-of-range vital signs may be repeated once at the discretion of the Investigator.
  • Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
  • Males with female partners must use a highly effective form of contraception (i.e., double barrier method, which includes a condom plus diaphragm with spermicide or condom plus spermicide or has had a vasectomy) or have no female partners of childbearing potential at the time of screening and for 90 days after the last dose of study treatment. Subjects must also agree not to donate sperm for the duration of the study and until 90 days after the last dose of study treatment.

Who cannot join

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, including the presence of laboratory abnormalities, that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  • Any serious medical condition, clinically significant laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
  • Tests positive for COVID-19 via polymerase chain reaction (PCR) test at check-in.
  • Recent history within 3 years of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic, or other major disorders.
  • Used any prescribed systemic or topical medication within 14 days of the first dose administration.
  • Used any non-prescribed systemic (including herbal medicines, e.g. St. John's Wort) or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements)
Show all 15Show fewer
  • Subjects who have any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
  • Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration or currently enrolled in any investigational trials.
  • Donated blood or plasma within 8 weeks preceding the first dose administration.
  • History of relevant drug and/or food allergies.
  • Any clinically significant allergic disease (excluding nonactive hay fever).
  • Self-reported history of drug abuse of at least 2 years prior to the first dose of study treatment, and/or positive drug screening test due to illicit drugs at screening or Day 1 of each period.
  • Self-report of more than 21 units of alcohol per week (1 unit of alcohol equals approximately 12 ounces of 5% alcohol by volume [ABV] beer, 8 ounces of 7% ABV malt liquor, 5 ounces of 12% ABV wine, 1.5 ounces 40% ABV [80 proof] distilled spirits [e.g., gin, rum, vodka, whiskey, etc.]), and/or positive alcohol screen at screening or Day 1 of each period.
  • Smokers or users of other tobacco products (e.g., chewing tobacco, or those using nicotine-containing products [i.e., patches, gum]) in the 3 months prior to screening, or positive urine cotinine test.
  • Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb), or tests positive for human immunodeficiency virus (HIV) antibodies at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Worldwide Clinical Trails Early Phase Services

    San Antonio, Texas, 78217

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Healthy
Being tested
Decitabine, Tetrahydrouridine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    Also called DEC

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

  • TetrahydrouridineDrug

    Also called THU

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

Study groups in NCT05816356
Study groupRoleWhat they receive
Modified release formulation of decitabine and tetrahydrouridineExperimentalA modified-release combination formulation of decitabine/THU (2.5 mg/100 mg per capsule given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water.
Receives: Drug: Decitabine; Drug: Tetrahydrouridine
Immediate release capsules of decitabine and tetrahydrouridineActive comparatorCapsules of THU are given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water, followed by a single oral dose of decitabine given 1 hour (± 5 min) later with approximately 240 mL (8 fluid ounces) of ambient temperature water.
Receives: Drug: Decitabine; Drug: Tetrahydrouridine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak decitabine and tetrahydrouridine concentration in plasma

    Maximum levels of drug (decitabine and tetrahydrouridine) in plasma over 24 hr

    Measured: 0 to 24 hours

  2. Decitabine and tetrahydrouridine drug level exposure over 24 hr

    Area under the plasma concentration time profile for decitabine and tetrahydrouridine

    Measured: 0 to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start24 Mar 2023
  3. Primary completion30 Jun 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, two-way crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816356
Sponsor's protocol ID
EPI-01A-001
Status last verified
Sep 2023
First submitted
31 Mar 2023
Last updated
22 May 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Decitabine and Tetrahydrouridine in people with Healthy, run by EpiDestiny, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak decitabine and tetrahydrouridine concentration in plasma (time frame: 0 to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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