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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Nurandociguat (BAY3283142) old tablet - SD
  Single dose (SD) in treatment A.
• Препарат Nurandociguat (BAY3283142) new tablet - SD
  Single dose (SD) in treatment B and C.
• Препарат Nurandociguat (BAY3283142) old tablet
  High dose once daily for 5 days.
• Препарат Nurandociguat (BAY3283142) new tablet
  Low dose once daily for 7 days, high dose once daily for 6 days.

Первичные конечные точки

• Optional scheme 1-3 - Cmax for nurandociguat [Срок оценки: 0-72 hours post dose]
• Optional scheme 1-3 - AUC for nurandociguat [Срок оценки: 0-72 hours post dose]
• Optional scheme 4 and 5 - Cmax,md for nurandociguat [Срок оценки: 0-24 hours post dose]
• Optional scheme 4 and 5 - AUCt,md for nurandociguat [Срок оценки: 0-24 hours post dose]

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• CRS Clinical Research Services Berlin GmbH — Berlin

Идентификаторы

NCT: NCT07722585 · 22700 · 2025-524176-36-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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