A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetics of Nurandociguat in Patients with Chronic Kidney Disease Under Fasted and Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of a new nurandociguat tablet compared to a reference product. This assessment is clinically relevant to ensure that the new formulation provides consistent systemic exposure to patients with chronic kidney disease. The secondary objective is to determine the impact of food consumption on the pharmacokinetics of the new formulation.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 19 to 44 years. Both male and female individuals are included, and the cohort is identified as a vulnerable population. No information regarding chronic kidney disease or other medical conditions was specified for this group.

This Phase 3 clinical trial utilizes a design to evaluate the pharmacokinetics of a new nurandociguat tablet in comparison to a reference formulation, specifically assessing the impact of food on absorption and metabolism in individuals with chronic kidney disease. The study sequence commences with a screening visit to assess eligibility. Subsequent study visits are conducted to monitor the bioavailability and processing of the medication. The protocol concludes with an end-of-study visit. The total duration of participant involvement is determined by the study design, and early termination may occur based on predefined clinical criteria.

The assessment of efficacy in this phase 3 clinical trial for Chronic Kidney Disease is not specified in the provided documentation.