Healthy VolunteersPhase 1NCT06291285
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People
A Phase 1 study testing Decitabine-THU in people with Healthy Volunteers, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Decitabine-THU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Feb 2024to 10 Jun 2024
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
- pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Decitabine-THU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine-THUDrug
Also called NDec
Orally administered immediate release tablets.
Decitabine-THUDrug
Also called NDec
Orally administered delayed release capsules.
| Study group | Role | What they receive |
|---|---|---|
| Formulation A followed by Formulation B | Experimental | 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. Receives: Drug: Decitabine-THU |
| Formulation B followed by Formulation A | Experimental | 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. Receives: Drug: Decitabine-THU |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose
Measured in hours*nanogram per milliliter (h*ng/mL).
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
Secondary outcomes (9)
AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose
Measured in h*ng/mL.
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose
Measured in nanogram per milliliter (ng/mL).
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose
Measured in ng/mL.
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
t½,DEC,SD: Terminal half-life for decitabine after a single dose
Measured in hours.
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose
Measured in hours.
Measured: 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
Measured in hours.
Measured: 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
Measured in hours.
Measured: 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
Measured in mean fluorescence intensity (MFI).
Measured: 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
Measured in micromoles per liter per minute (µmol/L/min).
Measured: Predose (Day 1) up to 48 hours post dose (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start27 Feb 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291285
- Sponsor's protocol ID
- NN7533-7587
- Other IDs
- U1111-1285-7491
- Status last verified
- Dec 2025
- First submitted
- 26 Feb 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06291285
- Acronym / sponsor ID
- NN7533-7587
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A followed by Formulation B | Experimental | Drug: Decitabine-THUParticipants 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. |
| Formulation B followed by Formulation A | Experimental | Drug: Decitabine-THUParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decitabine-THUAlso: NDecOrally administered immediate release tablets. | Drug | Formulation A followed by Formulation B, Formulation B followed by Formulation A |
| Decitabine-THUAlso: NDecOrally administered delayed release capsules. | Drug | Formulation A followed by Formulation B, Formulation B followed by Formulation A |
Primary outcome
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).
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine-THU in people with Healthy Volunteers, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 6 inclusion and 6 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.