Pharmacokinetic Evaluation of Zongertinib on Dabigatran, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects

The primary objective of this **pharmacokinetic trial** is to evaluate the effect of zongertinib on the plasma concentrations of four other medications: dabigatran, rosuvastatin, metformin, and furosemide in healthy male subjects. Understanding these interactions is clinically relevant as it can inform dosing adjustments and enhance the safety and efficacy of these medications when co-administered with zongertinib. No secondary objectives are specified for this study.

The clinical trial is a **pharmacokinetic trial** involving a study population exclusively composed of male subjects. The age range of participants is categorized as adults, specifically between 18 to 65 years old. The trial does not include any vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants were selected based on criteria that are not specified in the available data. There are no details provided about the general health status, lifestyle considerations such as diet or physical activity, or specific inclusion or exclusion criteria for this trial. The trial aims to assess pharmacokinetic parameters, although the main objective is not detailed in the provided information.

This clinical trial is a **pharmacokinetic trial** designed to evaluate the influence of zongertinib on the plasma concentrations of four other medications: dabigatran, rosuvastatin, metformin, and furosemide. The study is structured as a Phase 3 trial and is expected to commence recruitment on August 27, 2024, with an estimated completion date of October 15, 2024. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to receive either the investigational drug or a placebo, with neither the participants nor the investigators aware of the group assignments, thus maintaining the double-blind nature of the study.

The trial will include several study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo a series of follow-up visits at specified intervals to monitor drug levels, assess safety, and evaluate any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the pharmacokinetic interactions. The expected duration of participant involvement will be determined by the study protocol, with specific conditions outlined for early termination, such as adverse reactions or withdrawal of consent.

Participants will be involved in the study for the duration necessary to achieve the primary and secondary endpoints, as defined by the trial protocol. The study will adhere to rigorous ethical standards and regulatory requirements to ensure participant safety and data integrity throughout the trial period.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. Consequently, the trial documentation lacks comprehensive information on the treatment protocols and methodologies employed in the study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 27, 2024, with an estimated completion date of October 15, 2024. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The study will adhere to rigorous standards typical of Phase 3 trials, ensuring that the data collected is robust and reliable for evaluating the treatment's efficacy. The trial's design and execution will be aligned with regulatory requirements and scientific best practices to provide meaningful insights into the treatment's potential benefits.