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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

NCT07722585 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Nurandociguat (BAY3283142) old tablet - SD

Single dose (SD) in treatment A.

DRUG

Nurandociguat (BAY3283142) new tablet - SD

Single dose (SD) in treatment B and C.

DRUG

Nurandociguat (BAY3283142) old tablet

High dose once daily for 5 days.

DRUG

Nurandociguat (BAY3283142) new tablet

Low dose once daily for 7 days, high dose once daily for 6 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-28
Primary Completion
2026-10-28
Completion
2026-11-04

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722585 on ClinicalTrials.gov