A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

December 19, 2025 updated by: Novo Nordisk A/S

A Study to Investigate the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Decitabine and Tetrahydrouridine (NDec) When Administered Either as a Modified Release Formulation or an Immediate Release Formulation in Healthy Participants

This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH
  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • ICON-Salt Lake City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female.
  • Age 18 64 years (both inclusive) at the time of signing the informed consent.
  • Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.
  • Body mass index between 18.5-29.9 kilograms per square meter (kg/m^2) (both inclusive).
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

  • Platelet count greater than (>) 400*10^9/ Liter (L) at visit 1
  • Absolute neutrophil count less than or equal to (≤) 1.5*10^9/L at visit 1

  • Female who is:

    1. pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or
    2. of childbearing potential and not using highly effective contraceptive method and whose male partner is not using effective contraception, from screening until 6 months after the last dose of trial product
  • Male of reproductive age with female partner of childbearing potential who does not agree to use condoms and whose female partner of childbearing potential is not using a highly effective contraceptive measure (or adequate contraceptive measure as required by local regulation or practice) from signing the informed consent form (ICF) until 6 months after the last dose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Formulation A followed by Formulation B
Participants will receive a single oral dose of decitabine and tetrahydrouridine (THU) immediate release tablets (Formulation A) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods.
Drug: Decitabine-THU
Orally administered immediate release tablets.
Other Names:
  • NDec
Drug: Decitabine-THU
Orally administered delayed release capsules.
Other Names:
  • NDec
Experimental: Formulation B followed by Formulation A
Participants will receive a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU immediate release tablets (Formulation A) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods.
Drug: Decitabine-THU
Orally administered immediate release tablets.
Other Names:
  • NDec
Drug: Decitabine-THU
Orally administered delayed release capsules.
Other Names:
  • NDec

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours*nanogram per milliliter (h*ng/mL).
Predose (Day 1) up to 48 hours post dose (Day 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in h*ng/mL.
Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in nanogram per milliliter (ng/mL).
Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in ng/mL.
Predose (Day 1) up to 48 hours post dose (Day 3)
t½,DEC,SD: Terminal half-life for decitabine after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Predose (Day 1) up to 48 hours post dose (Day 3)
t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Predose (Day 1) up to 48 hours post dose (Day 3)
tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Predose (Day 1) up to 48 hours post dose (Day 3)
tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Predose (Day 1) up to 48 hours post dose (Day 3)
Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in mean fluorescence intensity (MFI).
Predose (Day 1) up to 48 hours post dose (Day 3)
Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose
Time Frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in micromoles per liter per minute (µmol/L/min).
Predose (Day 1) up to 48 hours post dose (Day 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN7533-7587
  • U1111-1285-7491 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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