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

NCT06291285 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN7533-7587U1111-1285-7491
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Predose (Day 1) up to 48 hours post dose (Day 3)

• Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose

  Predose (Day 1) up to 48 hours post dose (Day 3)

• Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose

  Predose (Day 1) up to 48 hours post dose (Day 3)

• t½,DEC,SD: Terminal half-life for decitabine after a single dose

  Predose (Day 1) up to 48 hours post dose (Day 3)

• t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose

  Predose (Day 1) up to 48 hours post dose (Day 3)

Study Arms (2)

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.

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.

Drug: Decitabine-THU

Interventions

Decitabine-THU DRUG

Orally administered immediate release tablets.

Also known as: NDec

Formulation A followed by Formulation B; Formulation B followed by Formulation A

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON-Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: February 27, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (1)