An Open-label, Randomized, Three-period, Crossover Study to compare the Pharmacokinetics of GB1211 upon dosing a capsule under fasting condition and a tablet under fasting and fed conditions in healthy volunteers.

The primary objective of this study is to evaluate the **pharmacokinetics** of GB1211 in healthy volunteers. This is achieved by comparing the pharmacokinetic profiles of GB1211 when administered as a capsule under fasting conditions and as a tablet under both fasting and fed conditions. Understanding the pharmacokinetics of GB1211 is clinically relevant as it provides insights into the drug's absorption, distribution, metabolism, and excretion, which are crucial for optimizing dosing regimens and ensuring therapeutic efficacy in conditions such as **non-small cell lung cancer** and **advanced liver fibrosis and cirrhosis**. No secondary objectives are specified for this study.

The clinical trial involves participants diagnosed with **Non-small Cell Lung Cancer** and **Advanced Liver Fibrosis and Cirrhosis**. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed in the available data.

The clinical trial is designed as an **open-label**, randomized, three-period, crossover study to evaluate the pharmacokinetics of GB1211 in healthy volunteers. The trial will compare the pharmacokinetics of a capsule administered under fasting conditions with a tablet administered under both fasting and fed conditions. The study is categorized as a Phase 3 trial and is expected to run from December 15, 2022, to July 31, 2023. Participants will be involved in the study for the duration of the trial, with specific conditions outlined for early termination, such as adverse events or non-compliance with study protocols.

The sequence of study visits includes an initial **screening** visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into different treatment sequences. Each treatment period will be followed by a washout phase to ensure no carryover effects between treatments. Follow-up visits will be scheduled to monitor the participants' health status and collect pharmacokinetic data. The end-of-study visit will conclude the trial, where final assessments will be conducted to ensure participant safety and gather any remaining data.

Participants are expected to adhere to the study schedule and protocol requirements throughout the trial. Any deviation from the protocol, such as non-compliance or withdrawal of consent, may result in early termination from the study. The trial aims to provide comprehensive data on the pharmacokinetics of GB1211, contributing to the understanding of its potential therapeutic applications in conditions such as **non-small cell lung cancer** and **advanced liver fibrosis and cirrhosis**.

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 treatments 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 offered regarding these aspects of the clinical trial.

The clinical trial is in Phase 3, with an estimated recruitment start date of December 15, 2022, and an estimated end date of July 31, 2023. Efficacy will be assessed through the evaluation of primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured schedule for measuring and collecting efficacy parameters, adhering to the standards expected in a Phase 3 trial. The analysis of these parameters will be conducted using scientifically validated methods appropriate for the trial phase. The trial's design and execution will ensure that efficacy assessments are objective and reliable, contributing to the overall evaluation of the treatment's effectiveness.