Evaluation of Carbamazepine's Impact on the Pharmacokinetics of Vepdegestrant in Healthy Adults with ER+/HER2+ Breast Cancer

The primary objective of this study is to estimate the effect of multiple doses of **Carbamazepine** on the pharmacokinetics (PK) of a single dose of **Vepdegestrant** in healthy adult participants. Understanding the interaction between these two drugs is clinically relevant as it may inform dosing strategies and safety considerations for patients, particularly those with **ER+/HER2 positive breast cancer**, who may be prescribed these medications concurrently. The study does not list any secondary objectives.

The clinical trial involves participants diagnosed with **ER+/HER2 positive breast cancer**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the pharmacokinetic effects of multiple doses of **carbamazepine** on a single dose of vepdegestrant in healthy adult participants. This study is a Phase 3 trial, employing a **randomized**, **double-blind**, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence on August 18, 2023, and conclude by December 4, 2023, with the total duration of the trial spanning approximately four months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into the study groups. The trial will include multiple follow-up visits to monitor the pharmacokinetic parameters and ensure participant safety. These visits will be scheduled at regular intervals throughout the study period. The end-of-study visit will be conducted to perform final assessments and gather comprehensive data on the study outcomes.

The expected length of participant involvement will align with the overall trial duration, with individual participation lasting until the end-of-study visit. 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 study aims to provide valuable insights into the interaction between carbamazepine and vepdegestrant, contributing to the understanding of their combined effects in the context of ER+/HER2 positive breast cancer treatment.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of August 18, 2023, with an estimated end date of December 4, 2023. The trial's efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints used to evaluate efficacy are not detailed in the provided data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design will ensure that efficacy assessments are conducted at appropriate intervals, using validated methods and tools, to provide reliable and scientifically sound results. The trial's objective is to gather comprehensive data to support the efficacy of the intervention under investigation, contributing to the overall understanding of its therapeutic potential.