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

References

• Eddleston M, Cohen AF, Webb DJ. Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Br J Clin Pharmacol. 2016;81(4):582–586.
   Google Scholar
• Kaur R, Sidhu P, Singh S. What failed BIA 10-2474 Phase I clinical trial? Global speculations and recommendations for future Phase I trials. J Pharmacol Pharmacother. 2016;7(3):120–126.
   Google Scholar
• Attarwala H. TGN1412: from Discovery to Disaster. J Young Pharm. 2010;2(3):332–336.
   Google Scholar
• Coates S, Täubel J, Lorch U. Practical risk management in early phase clinical trials. Eur J Clin Pharmacol. 2019;75(4):483–496.
   Google Scholar
• Lorch U, Berelowitz K, Ozen C, et al. The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Eur J Clin Pharmacol. 2012;68(5):543–551.
   Google Scholar
• Sibille M, Patat A, Caplain H, et al. A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group. Br J Clin Pharmacol. 2010;70(5):736–748.
   Google Scholar
• Kanamaru M, Nagashima S, Uematsu T, et al. Influence of 7-day hospitalization for Phase I study on the biochemical laboratory tests of healthy volunteers. Jpn J Clin Pharmacol Ther. 1989;20(3):493–504.
   Google Scholar
• Goldman SA. Causality assessment in premarketing drug clinical trials: regulatory evolution in the USA and ongoing concerns. Drug Saf. 2016;39(10):895–901.
   Google Scholar
• Rosenzweig P, Miget N, Brohier S. Transaminase elevation on placebo during phase I trials: prevalence and significance. Br J Clin Pharmacol. 1999;48(1):19–23.
   Google Scholar
• Kobayashi M, Yamada N, Shibata H, et al. Elevated serum transaminase values in volunteers after administration of placebo in a phase I study. Jpn J Clin Pharmacol Ther. 1993;24:493–496.
   Google Scholar
• Merz M, Seiberling M, Höxter G, et al. Elevation of liver enzymes in multiple dose trials during placebo treatment: are they predictable? J Clin Pharmacol. 1997;37(9):791–798.
   Google Scholar
• Roux C, Chevassus H, Farret A, et al. Selecting healthy volunteers in specific populations: a retrospective analysis of clinical and laboratory screening. Fundam Clin Pharmacol. 2010;24(1):121–127.
   Google Scholar
• Young TC, Srinivasan S, Vetter ML, et al. A systematic review and pooled analysis of select safety parameters among normal healthy volunteers taking placebo in phase 1 clinical trials. J Clin Pharmacol. 2017;57(9):1079–1087.
   Google Scholar
• Jarow JP, Moscicki R. Impact of expanded access on FDA regulatory action and product labeling. Ther Innov Regul Sci. 2017;51(6):787–789.
   Google Scholar
• Liu J, Li X, Zhang H, et al. S-amlodipine-bisoprolol combination therapy caused elevated transaminases and triglyceride levels in healthy Chinese subjects: a randomized controlled, open-label, multiple-dose pharmacokinetic interaction study. Expert Opin Drug Metab Toxicol. 2019;15(9):687–695.
   Google Scholar
• Rosenzweig P, Brohier S, Zipfel A. Data on placebo in healthy volunteers: impact of experimental conditions on safety, and on laboratory and physiological variables during phase I trials. Therapie. 1996;51(4):356–357.
   Google Scholar
• Purkins L, Love ER, Eve MD, et al. The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit. Br J Clin Pharmacol. 2004;57(2):199–208.
   Google Scholar
• Cai Z, Christianson AM, Ståhle L, et al. Reexamining transaminase elevation in Phase I clinical trials: the importance of baseline and change from baseline. Eur J Clin Pharmacol. 2009;65(10):1025–1035.
   Google Scholar
• Breithaupt-Groegler K, Coch C, Coenen M, et al. Who is a ‘healthy subject’?-consensus results on pivotal eligibility criteria for clinical trials. Eur J Clin Pharmacol. 2017;73(4):409–416.
   Google Scholar
• Bell JA, Carslake D, O’Keeffe LM, et al. Associations of body mass and fat indexes with cardiometabolic traits. J Am Coll Cardiol. 2018;72(24):3142–3154.
   Google Scholar
• Golik A, Rubio A, Weintraub M, et al. Elevated serum liver enzymes in obesity: a dilemma during clinical trials. Int J Obes. 1991;15(12):797–801.
   Google Scholar
• Azuma J, Seto Y, Mochizuki N, et al. Changes in the serum enzyme levels and the predicting factors during 2 weeks hospitalisation in healthy volunteers: a retrospective study. Jpn J Clin Pharmacol Ther. 1993;24:385–396.
   Google Scholar
• Irwin MI, Staton AJ. Dietary wheat starch and sucrose. Effect on levels of five enzymes in blood serum of young adults. Am J Clin Nutr. 1969;22(6):701–709.
   Google Scholar
• Porikos KP, Van Itallie TB. Diet-induced changes in serum transaminase and triglyceride levels in healthy adult men. Role of sucrose and excess calories. Am J Med. 1983;75(4):624–630.
   Google Scholar