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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Orally administered immediate release tablets.
Orally administered delayed release capsules.
ICON-Salt Lake City
Salt Lake City, Utah, United States
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose
Measured in hours\*nanogram per milliliter (h\*ng/mL).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose
Measured in h\*ng/mL.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose
Measured in nanogram per milliliter (ng/mL).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose
Measured in ng/mL.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
t½,DEC,SD: Terminal half-life for decitabine after a single dose
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose
Measured in hours.
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose
Measured in mean fluorescence intensity (MFI).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose
Measured in micromoles per liter per minute (µmol/L/min).
Time frame: Predose (Day 1) up to 48 hours post dose (Day 3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.