CRS Clinical Research Services Berlin GmbH
Berlin, 13627, Germany
NCT Number: NCT07722585
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 opening soon.
Get Notified18 year–58 year
All sexes
Interventional
Phase 1
Berlin, 13627, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
High dose once daily for 5 days.
Low dose once daily for 7 days, high dose once daily for 6 days.
Time frame: 0-72 hours post dose
Cmax=Maximum observed concentration
Time frame: 0-72 hours post dose
AUC=Area under the concentration time curve
Time frame: 0-24 hours post dose
Cmax,md=Cmax after multiple dosing
Time frame: 0-24 hours post dose
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
Time frame: From the first dose of study intervention up to 7 days after end of treatment with study intervention
Contact information is provided by the study sponsor or research team.
Bayer
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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