Decitabine-THU
DrugOrally administered immediate release tablets.
Other names: NDec
NCT Number: NCT06291285
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.
Looking for future studies?
Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orally administered immediate release tablets.
Other names: NDec
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours*nanogram per milliliter (h*ng/mL).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in h*ng/mL.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in nanogram per milliliter (ng/mL).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in ng/mL.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in mean fluorescence intensity (MFI).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Measured in micromoles per liter per minute (µmol/L/min).
Novo Nordisk A/S
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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