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

NCT ID: NCT06291285

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-06-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Decitabine-THU

Intervention Type: DRUG

Orally administered immediate release tablets.

Decitabine-THU

Intervention Type: DRUG

Orally administered delayed release capsules.

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.

Group Type: EXPERIMENTAL

Decitabine-THU

Intervention Type: DRUG

Orally administered immediate release tablets.

Decitabine-THU

Intervention Type: DRUG

Orally administered delayed release capsules.

Interventions

Decitabine-THU

Orally administered immediate release tablets.

Intervention Type: DRUG

Decitabine-THU

Orally administered delayed release capsules.

Intervention Type: DRUG

Other Intervention Names

NDec; NDec

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

ICON-Salt Lake City

Salt Lake City, Utah, United States

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

United States; Germany

Other Identifiers

U1111-1285-7491

Identifier Type: OTHER

Identifier Source: secondary_id

NN7533-7587

Identifier Type: -

Identifier Source: org_study_id