Phase 1 Study on Linaprazan Glurate's Impact on Pharmacokinetics of Repeated Antibiotic Doses in Helicobacter pylori Infection and GERD

The primary objective of this Phase 1 trial is to evaluate the effect of 7-days-repeated administration of **linaprazan glurate** on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants. This investigation is clinically relevant as it aims to understand potential interactions between linaprazan glurate and antibiotics, which could inform treatment strategies for conditions such as **Helicobacter pylori infection** and **GERD** (Gastroesophageal Reflux Disease). The study does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **Helicobacter pylori infection** and **GERD**. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific criteria, although these criteria have not been disclosed. Lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial aims to gather data from a diverse group of individuals to ensure comprehensive results.

The clinical trial is designed as an **open, single-arm, single-center, Phase 1** study to evaluate the effect of a 7-day repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants. The trial focuses on conditions such as **Helicobacter pylori infection** and **GERD**. The study is scheduled to commence recruitment on December 2, 2024, and is expected to conclude by March 30, 2025. Participants will be involved in the study for a duration that aligns with the trial's timeline, with specific visits structured to monitor and assess the pharmacokinetic interactions.

The sequence of study visits includes an initial inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will undergo a series of follow-up visits during the 7-day administration period. These visits are designed to collect data on the pharmacokinetics of the antibiotic when administered alongside linaprazan glurate. The end-of-study visit will occur after the completion of the administration period, where final assessments and data collection will take place to evaluate the primary and secondary endpoints of the trial.

Participant involvement is expected to last throughout the trial duration, with conditions for early termination including adverse events, withdrawal of consent, or any protocol deviations that may compromise the integrity of the study. The trial's design ensures that data collection and participant safety are prioritized, with all procedures conducted in accordance with regulatory standards and ethical guidelines.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, and frequency of administration. Additionally, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, that may be used in the study. Furthermore, the documentation lacks details on drug administration, dosing schedules, and participant compliance monitoring. As such, no further description of the treatments can be provided based on the available data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on December 2, 2024, with an estimated end date of March 30, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters, adhering to the standards expected in a Phase 3 clinical trial. The trial will utilize validated tools and instruments to ensure the accuracy and reliability of the efficacy assessments. The schedule for these assessments will be aligned with the trial's timeline, ensuring that data is collected at appropriate intervals to evaluate the treatment's impact effectively. The trial's design will ensure that all efficacy assessments are conducted in a manner that is consistent with clinical trial protocols and technical documentation standards.