Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NDec
Decitabine-THU · 1 trial · 1 indication
Measured in hours\*nanogram per milliliter (h\*ng/mL).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Decitabine-THU | DRUG | Orally administered immediate release tablets. |
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female. * Age 18 64 years (both inclusive) at the time o...
Decitabine-THU is an investigational small molecule combination developed by Novo Nordisk A/S. It pairs decitabine with tetrahydrouridine and is being studied in a Phase 1 clinical program. The specific disease indications being pursued have not been disclosed, and the compound remains in early clinical development.
Decitabine-THU is being developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. The company is the sponsor of the clinical program evaluating this small molecule combination.
Decitabine-THU is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for the program.
Decitabine-THU has been evaluated in one completed Phase 1 trial, NCT06291285, titled a study to test how either a capsule or a tablet with NDec works in the body of healthy people. The trial enrolled 44 healthy volunteers across the United States and Germany.
The Phase 1 trial NCT06291285 was a controlled, randomized study that enrolled 44 healthy volunteers aged 18 years and older of all sexes. It was not double blind and was conducted at sites in the United States and Germany. The study has been completed.