A Pharmacokinetic Study of Ibuzatrelvir Following Oral Administration in Healthy Adults

The primary objective of this study is to evaluate the pharmacokinetics of ibuzatrelvir in healthy adults following administration of different tablet formulations. This assessment is clinically significant to determine the absorption profile and systemic exposure of the study medicine. No secondary objectives were identified.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female subjects. The participants belong to vulnerable populations and fall within specific age ranges corresponding to codes 3 and 4. The population is characterized by the absence of coronavirus disease 2019.

This Phase 3 study is designed to evaluate the pharmacokinetics of ibuzatrelvir in healthy adults following the administration of different tablet formulations. The research methodology involves assessing how the study medicine is absorbed into the bloodstream. The clinical investigation consists of a screening visit to determine eligibility, followed by scheduled study visits to monitor the medication's uptake. The sequence includes follow-up visits and an end-of-study visit to complete the assessment. Participation in the trial is subject to early termination if specified conditions are met. The estimated duration for the study activities is from April 2026 to June 2026.

The assessment of efficacy in this phase 3 clinical trial regarding Coronavirus disease 2019 is not specified.