Pharmacokinetics of Norucholic Acid in Patients with Nonalcoholic Fatty Liver Disease and Primary Sclerosing Cholangitis with Renal Impairment

The primary objective of this clinical trial is to evaluate the pharmacokinetics of the investigational drug **norucholic acid** in individuals with renal impairment. This involves understanding how the drug is absorbed, distributed, metabolized, and excreted in this specific population. The clinical relevance of this study lies in optimizing dosing regimens and ensuring safety and efficacy for patients with kidney problems who may also suffer from conditions such as **nonalcoholic fatty liver disease (NAFLD)** and **primary sclerosing cholangitis (PSC)**. No secondary objectives have been specified for this trial.

The clinical trial involves participants diagnosed with **nonalcoholic fatty liver disease (NAFLD)** and **primary sclerosing cholangitis (PSC)**. The study population includes both male and female subjects, encompassing a broad age range from adolescents to adults. The trial also considers vulnerable populations, although specific details regarding the selection process or lifestyle considerations such as diet and physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study. Key inclusion or exclusion criteria have not been specified, and the general health status of the participants is not detailed in the available data.

The clinical trial is designed to evaluate the pharmacokinetics of **norucholic acid** in individuals with kidney problems, specifically focusing on its absorption, distribution, metabolism, and excretion. The study targets patients diagnosed with **nonalcoholic fatty liver disease (NAFLD)** and **primary sclerosing cholangitis (PSC)**. This is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to commence recruitment on October 2, 2023, and is projected to conclude by December 31, 2024.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. The trial will include multiple follow-up visits to monitor the participants' response to the investigational drug and to collect necessary data. These visits are crucial for assessing the drug's pharmacokinetics and ensuring participant safety. The end-of-study visit will mark the completion of the trial for each participant, where final assessments will be conducted.

The expected duration of participant involvement will vary depending on the specific protocol requirements but will generally span the entire trial period. Conditions that may lead to early termination from the study include adverse reactions to the investigational drug, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is structured to maintain scientific rigor and participant safety throughout its duration.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 2, 2023, with an estimated completion date of December 31, 2024. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger patient population. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.