Effect of moderate activity on liver function and serum lipid level in healthy subjects during the phase I clinical trial

• Published in: Expert opinion on drug metabolism & toxicology Vol. 16; no. 12; p. 1217
• Main Authors: Zhang, Hong, Liu, Ting, Li, Cuiyun, Li, Xiaojiao, Ding, Yanhua
• Format: Journal Article
• Language: English
• Published: England 01.12.2020
• Subjects: Adult; Alanine Transaminase - metabolism; Aspartate Aminotransferases - metabolism; Chemical and Drug Induced Liver Injury - etiology; Clinical Trials, Phase I as Topic; Exercise - physiology; Female; Humans; Length of Stay; Liver - drug effects; Liver Function Tests; Male; Randomized Controlled Trials as Topic; Risk Factors; Sex Factors; Triglycerides - blood; hypertriglyceridemia; moderate activity; transaminases; placebo; Phase I unit effect
• ISSN: 1744-7607
• DOI: 10.1080/17425255.2020.1823369

This study aims to investigate the incidence of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and triglyceride (TG) elevation, and the relationship with the phase I unit effect, and the moderate activity in healthy subjects enrolled in Phase I clinical trials. The demographic, AST, ALT, TG and activity data were collected from the placebo (146 subjects) groups and tested drug (885 subjects) groups in 20 phase I trials. Elevated AST, ALT and TG levels above the upper limit of normal were detected in 1.37%, 4.79% and 34.7% of subjects in the placebo group, respectively, 3.73%, 6.67% and 39.2% of subjects in the tested drug group, respectively. The incidence of elevated AST, ALT and TG increased with the extended hospital stay. However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay. The logistic regression analysis revealed that the baseline AST and ALT level, female gender, moderate exercise and duration of hospital stay were independent risk factors for ALT elevation. Moderate exercise during hospital stay may reduce the elevation rate of transaminases, but not TG, in subjects at phase I trials.