Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nurandociguat (BAY3283142) old tablet - SD
Nurandociguat old- SD · 1 trial · 1 indication
Cmax=Maximum observed concentration
AUC=Area under the concentration time curve
Cmax,md=Cmax after multiple dosing
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Optional Scheme 1-3: Treatment A-C-B | EXPERIMENTAL | 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. |
| Optional Scheme 1-3: Treatment B-A-C | EXPERIMENTAL | 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. |
| Optional Scheme 1-3: Treatment B-C-A | EXPERIMENTAL | 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. |
| Optional Scheme 1-3: Treatment C-A-B | EXPERIMENTAL | 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. |
| Optional Scheme 1-3: Treatment C-B-A | EXPERIMENTAL | 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. |
| Optional Scheme 4-5 | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
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), electrocar...
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Nurandociguat is an investigational small molecule being developed for chronic kidney disease. It is currently in Phase 1 clinical development. The drug is being studied to understand how a new tablet formulation is absorbed and processed in the body compared to an older tablet formulation.
Nurandociguat is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical trials for chronic kidney disease.
Nurandociguat is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the pharmacokinetics of a new tablet formulation in healthy volunteers and patients with chronic kidney disease.
Nurandociguat is being studied in one Phase 1 clinical trial registered as NCT07722585. This trial is recruiting 18 participants in Germany to evaluate how a new tablet is absorbed and processed in the body compared to an old tablet, and how food affects absorption. The study is controlled but not blinded.
Nurandociguat is also known as Nurandociguat (BAY3283142) old tablet. The drug is being studied in a clinical trial that compares a new tablet formulation to this older tablet formulation to assess differences in absorption and processing in the body.