Event Abstract Back to Event VARIABILITY OF CLINICAL CHEMISTRY PARAMETERS IN HEALTHY MALE VOLUNTEERS PRIOR TO DRUG ADMINISTRATION – AN OVERVIEW OF BAYER IN-HOUSE PHASE I TRIALS FROM 2000 – 2013 Michael F. Boettcher1* and Georg Wensing1 1 Bayer AG, Department of Clinical Pharmacology CV/HEM, Germany Introduction: Recently consensus results on pivotal eligibility criteria for healthy volunteers (HVs) for clinical trials were published. Baseline evaluations immediately prior to dosing were not recommended to confirm inclusion/exclusion criteria. Method: We reviewed all BAYER Phase I trials performed at the Institute of Clinical Pharmacology (Wuppertal) and ClinPharm Cologne between 2000 and 2013. Key parameters were: AST, ALT, GLDH, γGT, total bilirubin, CK, Amylase, lipase, creatinine. All parameters were compared at screening, at 24 hours and 0 hours before dosing. Results: In total, more than 35712 blood samples from 4300 healthy male subjects (aged 18-70 years) were investigated. A wide variability of laboratory parameters exceeding the upper limit of normal (ULN) at all time points was observed. Generally, the incidence of values above ULN is reduced from screening, to 24 and 0 hours before administration. However, despite of a reduced number of HVs from screening to 24 and 0 hours due to rigid inclusion/exclusion criteria there is still a substantial percentage of values above ULN 24h and 0h predose. AST and γGT values are less affected. Conclusion: A 24h predose lab sample may help to confirm inclusion/exclusion criteria and reduce the number of HVs with abnormal lab values entering the trial. A 0 hour sample should be mandatory to interpret abnormal values under treatment. Keywords: variability, Phase I, Healthy male subjects, Clinical chemistry parameters, prior drug administration Conference: EUFEMED 2017, London, United Kingdom, 17 May - 19 May, 2017. Presentation Type: Poster Topic: EUFEMED 2017 CONFERENCE Citation: Boettcher MF and Wensing G (2019). VARIABILITY OF CLINICAL CHEMISTRY PARAMETERS IN HEALTHY MALE VOLUNTEERS PRIOR TO DRUG ADMINISTRATION – AN OVERVIEW OF BAYER IN-HOUSE PHASE I TRIALS FROM 2000 – 2013. Front. Pharmacol. Conference Abstract: EUFEMED 2017. doi: 10.3389/conf.fphar.2017.62.00001 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 29 Aug 2017; Published Online: 25 Jan 2019. * Correspondence: Dr. Michael F Boettcher, Bayer AG, Department of Clinical Pharmacology CV/HEM, Wuppertal, Germany, michael-friedrich.boettcher@bayer.com Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Michael F Boettcher Georg Wensing Google Michael F Boettcher Georg Wensing Google Scholar Michael F Boettcher Georg Wensing PubMed Michael F Boettcher Georg Wensing Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.
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