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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

17 août 2026 mis à jour par: Bayer

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

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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

18

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Berlin, Allemagne, 13627
        • Recrutement
        • CRS Clinical Research Services Berlin GMBH

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Optional Scheme 1-3: Treatment A-B-C
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.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 1-3: Treatment A-C-B
Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 1-3: Treatment B-A-C
Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old 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.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 1-3: Treatment B-C-A
Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 1-3: Treatment C-A-B
Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 1-3: Treatment C-B-A
Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
Expérimental: Optional Scheme 4-5
Participants will receive nurandociguat new tablet for 7 days at a lower starting dose. Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days).
High dose once daily for 5 days.
Low dose once daily for 7 days, high dose once daily for 6 days.

Que mesure l'étude ?

Principaux critères de jugement

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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 juillet 2026

Achèvement primaire (Estimé)

28 octobre 2026

Achèvement de l'étude (Estimé)

4 novembre 2026

Dates d'inscription aux études

Première soumission

17 juillet 2026

Première soumission répondant aux critères de contrôle qualité

21 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2026

Dernière vérification

17 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.

As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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