Pharmacokinetics of Mavodelpar in Subjects with Varying Degrees of Hepatic Impairment: A Phase 1, Open-Label, Single-Dose Study

The primary objective of this study is to evaluate the **pharmacokinetics** of Mavodelpar in subjects with varying degrees of **impaired hepatic function**. This is clinically relevant as it aims to understand how liver impairment affects the absorption, distribution, metabolism, and excretion of Mavodelpar, which is crucial for determining appropriate dosing and safety in patients with liver dysfunction. The study will include subjects with normal hepatic function as well as those with mild, moderate, and severe hepatic impairment, classified according to the Child-Pugh score.

The clinical trial involves a total of **32 participants** divided into four distinct groups based on their hepatic function. The study population includes both male and female subjects, with an age range that spans from young adults to middle-aged individuals. Participants are categorized into groups with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and severe hepatic impairment (Child-Pugh C). The trial does not focus on a vulnerable population, and the selection criteria for participants are not specified by the sponsor. Lifestyle considerations such as diet, physical activity, or habits are not detailed in the provided data. The sponsor has not disclosed the total number of participants in the study.

The clinical trial is a **Phase 1, open-label, single-dose study** designed to evaluate the pharmacokinetics of Mavodelpar in subjects with **impaired hepatic function**. The study will include four distinct groups based on hepatic function: Group 1 will consist of 10 healthy subjects with normal hepatic function, Group 2 will include 8 subjects with mild hepatic impairment (Child-Pugh A, score 5-6), Group 3 will have 8 subjects with moderate hepatic impairment (Child-Pugh B, score 7-9), and Group 4 will comprise 6 subjects with severe hepatic impairment (Child-Pugh C, score 10-15). Each participant will receive a single dose of the investigational product.

The trial is expected to commence recruitment on June 1, 2023, and is estimated to conclude by November 16, 2023. The study involves a sequence of visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following the administration of the investigational product, participants will undergo follow-up visits to monitor pharmacokinetic parameters and assess safety. The end-of-study visit will mark the completion of the trial for each participant, where final assessments will be conducted.

Participant involvement is anticipated to last for the duration of the study, from the initial screening through to the end-of-study visit. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other reason deemed necessary by the investigator for the safety of the participant. The study is structured to ensure rigorous monitoring and data collection to achieve its objectives effectively.

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 in the trial documentation.

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 in Phase 3, with an estimated recruitment start date of June 1, 2023, and an estimated end date of November 16, 2023. Efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints used to evaluate efficacy are not detailed in the provided data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the standards expected in a Phase 3 trial. The trial's design will ensure that efficacy assessments are conducted at predetermined intervals, although the exact schedule and methods are not specified. The trial will utilize appropriate tools and instruments to ensure the accuracy and reliability of efficacy assessments, consistent with clinical trial protocols. The focus will be on obtaining scientifically valid results to determine the efficacy of the intervention under investigation.