Status and phase
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Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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