Evaluation of the Impact of Tolinapant (ASTX660) on OCT1, OCT2, and MATE1 Substrate Pharmacokinetics in Healthy Volunteers

The primary objective of this study is to evaluate the effect of **ASTX660 (tolinapant)** on the pharmacokinetics of substrates of **OCT1**, **OCT2**, and **MATE1** in healthy volunteers. Understanding these interactions is clinically relevant as it may inform potential drug-drug interactions and optimize dosing regimens for medications that are substrates of these transporters. No secondary objectives are specified for this study.

The clinical trial involves **healthy volunteers** with an age range corresponding to categories 3 and 4, which typically include adults and older adults. The study population comprises both male and female participants. The trial does not focus on individuals with specific medical conditions, as it targets a healthy cohort. The sponsor has not provided the total number of participants involved in the study. Participants were selected without specific lifestyle considerations such as diet or physical activity being highlighted. The trial includes a vulnerable population, although specific details regarding this aspect are not disclosed. The sponsor has not provided detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the effect of **ASTX660 (tolinapant)** on the pharmacokinetics of substrates of OCT1, OCT2, and MATE1 in healthy volunteers. 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 recruitment on November 20, 2023, and is projected to conclude by February 22, 2024, marking an overall duration of approximately three 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 different study arms. Throughout the trial, several follow-up visits will be scheduled to monitor the pharmacokinetic parameters and ensure participant safety. These visits will include assessments such as blood sampling and clinical evaluations. The end-of-study visit will occur after the final follow-up, where comprehensive data collection will be completed, and participants will be debriefed.

The expected length of participant involvement is contingent upon the study schedule, with each participant anticipated to be involved for the full duration of the trial unless specific conditions necessitate early termination. Such conditions may include adverse events, non-compliance with study protocols, or withdrawal of consent. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific information, additional relevant details about drug administration, dosing schedules, and participant compliance monitoring are also not included. The absence of data on the experimental and non-experimental treatments limits the ability to provide a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on November 20, 2023, with an estimated completion date of February 22, 2024. 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 at predetermined timepoints throughout the study duration. The use of validated scales, laboratory tests, or patient-reported outcomes may be involved in the assessment process, although specific tools or instruments are not mentioned. The trial's objective is to provide robust data on the efficacy of the intervention under investigation, contributing to the understanding of its potential benefits in the targeted medical condition.