Evaluation of Food Effect and Pharmacokinetics of DF2755A in Single and Multiple Ascending Doses in Healthy Subjects with Interstitial Cystitis/Bladder Pain Syndrome

The primary objective of this study is to evaluate the pharmacokinetics and safety of DF2755A following single and multiple ascending doses in healthy participants. This assessment is critical to characterize the absorption, distribution, and excretion profiles of the compound while determining the impact of food intake on its systemic exposure. The study also aims to establish the safety and tolerability parameters across different dose levels.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, within the age range of 18 to 45 years. The cohort includes vulnerable populations. The participants are characterized by the absence of interstitial cystitis/bladder pain syndrome.

This Phase 1 clinical trial is designed as a food effect, single-ascending dose, and multiple-ascending dose study to evaluate the pharmacological properties of DF2755A in healthy participants. The research methodology utilizes a controlled design to assess the impact of food intake on the drug. The study sequence begins with a screening visit to determine eligibility. Following screening, participants undergo various study visits for dose administration and monitoring, concluding with an end-of-study visit. The total duration of study involvement is determined by the specific dosing regimen assigned. Early termination from the study may occur based on predefined safety criteria or protocol deviations.

The assessment of efficacy in this Phase 3 clinical trial for interstitial cystitis/bladder pain syndrome remains to be defined. No specific parameters, endpoints, or measurement schedules have been provided in the source documentation.