Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects

PurposeThis study aims to investigate the effect of food intake on the pharmacokinetics of TQ05105 tablets in healthy Chinese subjects, and to evaluate the safety in these subjects.MethodsThis Phase I clinical trial involved healthy subjects who received a single oral dose of 15 mg TQ05105, with a 2-day washout period between each period. The plasma concentrations of TQ05105 and its metabolite TQ12550 were quantified using a validated liquid chromatography-tandem mass spectrometry method. Safety assessments were conducted throughout the study.ResultsThe study enrolled 16 healthy Chinese subjects (10 males and 6 females). Compared with the fasting condition, the postprandial administration of TQ05105 resulted in significant reductions in the maximum concentration (Cmax) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (Tmax) and half-life (t1/2) of TQ05105 and its metabolite were prolonged under postprandial conditions. No serious adverse events were reported during the study.ConclusionThe findings demonstrate that food intake significantly alters the pharmacokinetic parameters of TQ05105 and its metabolite TQ12550, with a notable decrease in Cmax and AUC, and an increase in Tmax and t1/2. The single dose of the drug was well tolerated.Registration informationThis trial had registered at the Clinical Trials.gov on August 08, 2023 (https://clinicaltrials.gov, NCT05982106).