NCT06291285

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Decitabine-THU	Orally administered immediate release tablets.
DRUG	Decitabine-THU	Orally administered delayed release capsules.

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2024-03-04
• Last updated: 2025-12-29

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study