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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-7491 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A followed by Formulation B | Experimental | Participants will receive a single oral dose of decitabine and tetrahydrouridine (THU) immediate release tablets (Formulation A) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods. |
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| Formulation B followed by Formulation A | Experimental | Participants will receive a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU immediate release tablets (Formulation A) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine-THU | Drug | Orally administered immediate release tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Predose (Day 1) up to 48 hours post dose (Day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose | Measured in h*ng/mL. | Predose (Day 1) up to 48 hours post dose (Day 3) |
| Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON-Salt Lake City | Salt Lake City | Utah | 84124 | United States | ||
| Profil Institut für Stoffwechselforschung GmbH |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Decitabine-THU | Drug | Orally administered delayed release capsules. |
|
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Measured in nanogram per milliliter (ng/mL). |
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | Predose (Day 1) up to 48 hours post dose (Day 3) |
| Neuss |
| 41460 |
| Germany |