Assessment of CHF6795's Impact on Midazolam, Repaglinide, and Rosuvastatin Pharmacokinetics in Healthy Volunteers with Chronic Cough

The primary objective of this study is to evaluate the effect of **CHF6795** on the pharmacokinetics of **midazolam**, **repaglinide**, and **rosuvastatin** in healthy subjects. Understanding these interactions is clinically relevant as it may inform dosing adjustments and safety considerations when these drugs are co-administered, particularly in patients with **chronic cough** who may require these medications. The study does not specify any secondary objectives.

The clinical trial focuses on individuals diagnosed with **chronic cough**. The study population includes both male and female participants, with an age range of 18 to 64 years. 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. Lifestyle considerations such as diet, physical activity, or habits are not specified. The trial aims to gather insights into the condition within the specified demographic, ensuring a comprehensive understanding of the disease's impact across a diverse group.

The clinical trial is designed to evaluate the effect of **CHF6795** on the pharmacokinetics of midazolam, repaglinide, and rosuvastatin in healthy subjects. This study 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 February 19, 2024, and is estimated to conclude by May 12, 2024, making the overall duration approximately three months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards for inclusion. Following successful screening, participants will be randomized into different study arms. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health status, adherence to the study protocol, and any potential side effects of the investigational product. These visits are crucial for collecting data on the pharmacokinetics of the drugs involved.

The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather data on the primary and secondary endpoints. The expected length of participant involvement is aligned with the trial's duration, approximately three months, unless early termination is warranted. Conditions that may lead to early termination include adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines to ensure the safety and well-being of all participants.

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 within the context of a Phase 3 study. The trial is scheduled to commence recruitment on February 19, 2024, with an estimated completion date of May 12, 2024. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that efficacy is evaluated systematically and objectively. The absence of specific endpoints or measurement tools in the provided data suggests that these details will be outlined in the full trial protocol, which will guide the collection and analysis of efficacy data throughout the study duration.