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

ABSTRACT

Background

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.

Methods

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.

Results

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.

Conclusion

Moderate exercise during hospital stay may reduce the elevation rate of transaminases, but not TG, in subjects at phase I trials.

KEYWORDS:

• Phase I unit effect
• placebo
• transaminases
• hypertriglyceridemia
• moderate activity

Author contributions

H. Zhang, T. Liu and Y. Ding designed this study. C. Li, X. Li performed the clinic trials. H. Zhang analyzed the data. H. Zhang and Y. Ding wrote and edited the manuscript and prepared the figures.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China (Project: 81602897).