Poster #038:Profiling Adverse Events and Laboratory Measurements in Healthy Volunteers Who Received Placebo in Abb Vie Phase 1 Trials

摘要

Statement of Purpose, Innovation or Hypothesis: The objective was to describe adverse events (AEs) and changes in laboratory test results from baseline for healthy volunteers administered placebo in Phase 1 trials. Description of Methods and Materials: Sixty-eight Phase 1 studies in healthy volunteers (n = 1,091; 74% males, 56% white, mean age 34 y and mean weight 75 kg) who received single or multiple placebo administrations were extracted from AbbVie clinical databases (2007-2014). The period of placebo administration ranges from 1-21 days. Treatment-emergent AEs were summarized in MedDRA terms by frequency and percentage. Clinical laboratory measurements hematology and chemistry values were analyzed by paired t-test for comparing the baseline and the maximum change after multiple placebo administrations. Data and Results: During single and multiple placebo administrations, 23% and 44%o f the subjects, respectively, experienced at least one AE. Nervous system disorder was the most common, including headache and dizziness in 11% and 7% of the subjects, respectively. The vast majority of lab measurements showed statistically-significant changes after multiple placebo administrations. The complete list of changes in lab results is shown in Table 1. The greatest shift in lab values from normal to abnormal following placebo administrations occurred in 10% or more of subjects for levels of cholesterol and triglycerides. Interpretation, Conclusion or Significance: Prior to ascribing clinical significance to the laboratory value changes and the AEs occurring during Phase 1 trials, study investigators should consider the quantitative changes from baseline in clinical laboratory values and the AE occurrence that may be attributed to the ambient conditions in the study. The present analyses from over 1,000 subjects who received placebo in AbbVie Phase 1 trials provide some reference to aid in such quantitative assessments. The studies were funded by AbbVie. AbbVie contributed to the study design, research and interpretation of data; writing, reviewing and approving the publication. All authors are AbbVie employees and may hold AbbVie stocks or options.