protocolSection identificationModule nctId: NCT06291285, orgStudyIdInfo id: NN7533-7587, secondaryIdInfos id: U1111-1285-7491, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-07-11, completionDateStruct date: 2024-07-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Decitabine-THU, interventions name: Decitabine-THU, outcomesModule primaryOutcomes measure: AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose, secondaryOutcomes measure: AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose, secondaryOutcomes measure: Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose, secondaryOutcomes measure: Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose, secondaryOutcomes measure: t½,DEC,SD: Terminal half-life for decitabine after a single dose, secondaryOutcomes measure: t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose, secondaryOutcomes measure: tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose, secondaryOutcomes measure: tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose, secondaryOutcomes measure: Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose, secondaryOutcomes measure: Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON-Salt Lake City, city: Millcreek, state: Utah, zip: 84124, country: United States, geoPoint lat: 40.68689, lon: -111.87549, locations facility: Profil Institut für Stoffwechselforschung GmbH, city: Neuss, zip: 41460, country: Germany, geoPoint lat: 51.19807, lon: 6.68504, hasResults: False