drugset / Trial / NCT06291285

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

NCT06291285

Phase 1 Completed 44 enrolled Novo Nordisk A/S
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2024-02-27
Primary completion
2024-06-10
Completion
2024-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule Oral
Subject Tetrahydrouridine Small molecule Oral

Indications

No indication recorded.