A Phase I Study to Evaluate the Cardiovascular Safety of Vicadrostat in Healthy Volunteers

The primary objective of this study is to evaluate the effect of vicadrostat on the heart in healthy volunteers. This investigation is clinically relevant to assess potential cardiovascular impacts of the compound. The study scope includes safety (4) and pharmacodynamic (7) assessments.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants fall within the age range represented by code 3.

This Phase 3, randomized, double-blind, controlled clinical trial is designed to evaluate the effects of vicadrostat on the cardiovascular system in healthy volunteers. The study protocol involves a sequence of scheduled visits, beginning with a screening visit to assess eligibility. Subsequent follow-up visits will be conducted to monitor physiological responses, concluding with an end-of-study visit. The total duration of participant involvement is determined by the clinical monitoring requirements established in the protocol. Early termination from the study may occur if specific safety criteria or predefined withdrawal conditions are met.

The clinical trial is designed to evaluate efficacy in healthy volunteers. No specific efficacy endpoints, assessment tools, or measurement schedules are provided in the study documentation.