Recruiting

Chronic Kidney Disease

Bayer Identifier:

22700

ClinicalTrials.gov Identifier:

NCT07722585

EudraCT Number:

Not Available

EU CT Number:

Not Available

A study to learn about how a new nurandociguat tablet is absorbed and processed in the body compared to an old tablet and how food affects the way the new tablet is absorbed and processed in the body

Trial purpose

Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.
The main purposes of the study are
•   To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as "pharmacokinetics [PK]" measurement) compared to an old tablet when taken without food.
•   To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).
To do this, researchers will take blood samples from the participants and measure:
•   Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants’ plasma
•   Area under the concentration time curve (AUC): the total amount of nurandociguat in participants’ plasma over time
Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.
Only healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:
•   Treatment A: Nurandociguat old tablet, taken without food
•   Treatment B: Nurandociguat new tablet, taken without food
•   Treatment C: Nurandociguat new tablet, taken with food
Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.
•   For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.
•   The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).
The researchers will closely monitor and manage any medical problems that the participants may have during the study.

Key Participants Requirements

Sex

All

Age

18 - 58 Years

Inclusion Criteria

- Participant must be 18 to 58 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.
- Body Mass Index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight above or equal 60 kg.
- Male and female.

Exclusion Criteria

- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines within the last 14 days before the first study intervention administration.
- Special diets preventing the participants from eating the standard meals during the study.
- Participant is unable or unwilling to comply with study restrictions.

Trial summary

Enrollment Goal

Trial Dates

July 2026 - November 2026

Phase

Phase I

Could I Receive a placebo

Products

Nurandociguat, BAY 3283142

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Recruiting	CRS Clinical Research Services Berlin GmbH	Berlin, 13627, Germany

Primary Outcome

Optional scheme 1-3 – Cmax for nurandociguat
Cmax=Maximum observed concentration
Time Frame:
0-72 hours post dose
Optional scheme 1-3 – AUC for nurandociguat
AUC=Area under the concentration time curve
Time Frame:
0-72 hours post dose
Optional scheme 4 and 5 – Cmax,md for nurandociguat
Cmax,md=Cmax after multiple dosing
Time Frame:
0-24 hours post dose
Optional scheme 4 and 5 – AUCt,md for nurandociguat
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
Time Frame:
0-24 hours post dose

Secondary Outcome

Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame:
From the first dose of study intervention up to 7 days after end of treatment with study intervention

Trial design

A single center, open-label study assessing the relative bioavailability of a new nurandociguat tablet formulation versus an existing formulation and investigating the food effect of the new tablet formulation

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.