NCT07722585|Not Yet RecruitingPhase 1

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

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

Bayer ClinicalTrials.gov

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2 other identifiers

227002025-524176-36-00

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2026

StartedJul 2026

CompletionNov 2026

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

3mo left

Started Jul 2026

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

Study Progress4%

Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 17, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed

5 days until next milestone

Study Start

First participant enrolled

July 28, 2026

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 17, 2026

Last Update Submit

July 21, 2026

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (1)

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

Study Arms (7)

Optional Scheme 1-3: Treatment A-B-C

EXPERIMENTAL

Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration.