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

Sponsor
Bayer
Study ID
NCT07722585
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 58 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 28, 2026
Status verified
Aug 2026
Primary completion
Oct 28, 2026
Completion
Nov 4, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: 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).
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Optional scheme 1-3 - Cmax for nurandociguat [ Time Frame: 0-72 hours post dose ]

Central Contacts

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