Pharmacokinetics and Safety Assessment of Buloxibutid (C21) Oral Formulations in Idiopathic Pulmonary Fibrosis: A Randomized, Open-Label, Cross-Over Study

The primary objective of this study is to assess the **pharmacokinetics** and safety of three oral solid formulations of buloxibutid (C21) in healthy male and female participants. This evaluation is clinically relevant as it provides critical information on the absorption, distribution, metabolism, and excretion of the drug, which is essential for determining the appropriate dosage and ensuring patient safety. The study focuses on understanding how these formulations behave in the body, which is crucial for the treatment of **idiopathic pulmonary fibrosis**. No secondary objectives are provided in the available data.

The clinical trial focuses on participants diagnosed with **idiopathic pulmonary fibrosis**. The study population includes both male and female subjects, with an age range categorized as adults. The trial involves a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on criteria that are not disclosed in the available data. Information regarding lifestyle considerations such as diet, physical activity, or habits is not specified. The trial aims to gather insights from a diverse group of individuals affected by this condition, ensuring a comprehensive understanding of the disease's impact across different demographics.

The clinical trial is designed as a **randomized**, open-label, 5-period, cross-over study to evaluate the pharmacokinetics and safety of three oral solid formulations of buloxibutid (C21) in healthy male and female participants. The trial is focused on the condition of **idiopathic pulmonary fibrosis** and is categorized as a Phase 3 study. The estimated recruitment start date is May 19, 2025, with an anticipated end date of August 24, 2025, indicating a total trial duration of approximately three months.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive the study drug in a cross-over manner across five distinct periods. Each period will involve administration of one of the three formulations, with appropriate washout intervals to ensure accurate pharmacokinetic assessment. Follow-up visits will be scheduled to monitor safety and collect pharmacokinetic data at specified intervals throughout the trial. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to ensure participant safety and gather comprehensive data for analysis.

The expected length of participant involvement is aligned with the trial's duration, spanning the entire three-month period. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure rigorous data collection while maintaining participant safety and adherence to ethical standards.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

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. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 19, 2025, with an estimated completion date of August 24, 2025. 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 provided data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent and reliable. The trial's design and execution will adhere to the standards expected in a Phase 3 clinical trial, focusing on the rigorous evaluation of the investigational product's efficacy.