A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

Healthy Volunteers Clinical Trial

Official title:

A Study to Investigate the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Decitabine and Tetrahydrouridine (NDec) When Administered Either as a Modified Release Formulation or an Immediate Release Formulation in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291285
• Other study ID #: NN7533-7587
• Secondary ID: U1111-1285-7491
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2024
• Est. completion date: July 11, 2024

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 11, 2024
• Est. primary completion date: July 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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 of signing the informed consent.

• Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.

• Body mass index between 18.5-29.9 kilograms per square meter (kg/m^2) (both inclusive).

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

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:

1. pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or

2. of childbearing potential and not using highly effective contraceptive method and whose male partner is not using effective contraception, from screening until 6 months after the last dose of trial product

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Decitabine-THU
Orally administered immediate release tablets.
• Decitabine-THU
Orally administered delayed release capsules.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss
United States	ICON-Salt Lake City	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose	Measured in nanogram per milliliter (ng/mL).	Predose (Day 1) up to 48 hours post dose (Day 3)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)