Effect of Carboxylesterase 2 and CYP3A4 Inhibition on the Pharmacokinetics of Buloxibutid in Healthy Volunteers: A Randomized Open-Label Drug-Drug Interaction Study

This study is designed to evaluate the impact of carboxylesterase 2 (CES2) and CYP3A4 inhibition on the pharmacokinetics of buloxibutid. The primary objective is to determine how the inhibition of these specific enzymes alters the metabolic profile and systemic exposure of the study drug in healthy volunteers. This evaluation is clinically relevant for understanding potential drug-drug interactions and ensuring predictable drug disposition. The trial scope includes 6: Pharmacokinetic.

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 44 years. The cohort includes vulnerable populations. The research pertains to idiopathic pulmonary fibrosis.

This is a Phase 3, randomised, open-label, single-centre, drug-drug-interaction trial designed to evaluate the impact of carboxylesterase 2 (CES2) and CYP3A4 inhibition on the pharmacokinetics of buloxibutid. The study involves healthy volunteers. The clinical sequence begins with a screening visit to assess eligibility. Subsequent study visits are conducted to monitor the pharmacokinetic profile of the investigational product. The trial period includes follow-up assessments and an end-of-study visit. Participation continues for the duration specified by the protocol, although early termination may occur according to predefined clinical criteria.

The assessment of efficacy in this Phase 3 clinical trial involves the evaluation of outcomes related to idiopathic pulmonary fibrosis. Specific parameters for determining therapeutic effectiveness are not defined in the provided documentation.