Investigators at Bristol-Myers Squibb Co. Release New Data on Clinical Trials and Studies (A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials)
By a News Reporter-Staff News Editor at Clinical Trials Week -- Fresh data on Clinical Research - Clinical Trials and Studies are presented in a new report. According to news reporting out of Princeton, New Jersey, by NewsRx editors, research stated, "A systematic review of the Bristol-Myers Squibb normal healthy volunteers (NHVs) database identified phase 1 trials that included NHVs administered placebo with the aim of characterizing normal inter-and intraindividual safety parameter variability. Twenty-five single and multiple ascending dose studies, median duration 28 (2 to 63) days, were included in the pooled analysis (355 NHVs)."
Financial support for this research came from Bristol-Myers Squibb (see also Clinical Research - Clinical Trials and Studies).
Our news journalists obtained a quote from the research from Bristol-Myers Squibb Co., "Laboratory evaluations, vital signs, electrocardiograms, and adverse events were assessed. The most commonly occurring adverse event was headache (28 [7.9%] NHVs; 519.5 events/100 person-years). During the dosing period (on placebo), evaluations showed 5.1 events/100 measures of alanine aminotransferase and 7.3 events/100 measures of creatine kinase 1? above the upper limit of normal. Alanine aminotransferase and creatine kinase elevations occurred in 28 (7.9%) and 39 (11.0%) NHVs, respectively; 105 (30.3%) NHVs had low and 46 (13.3%) had high diastolic blood pressure."
According to the news editors, the research concluded: "This analysis may inform future study designs and provide a context for interpretation of safety signals in early phase clinical trials."
For more information on this research see: A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials. Journal of Clinical Pharmacology, 2017;():. Journal of Clinical Pharmacology can be contacted at: SAGE Publications, USA , 2455 Teller Road, Thousand Oaks, CA 91320, USA. (Sage Publications - www.sagepub.com/; Journal of Clinical Pharmacology - jcp.sagepub.com)
Our news journalists report that additional information may be obtained by contacting T.C. Young, Bristol-Myers Squibb, Princeton, NJ, United States. Additional authors for this research include S. Srinivasan, M.L. Vetter, V. Sethuraman, Z. Bhagwagar, R. Zwirtes, P. Narasimhan, T. Chuang and B.J Smyth.
Publisher contact information for the Journal of Clinical Pharmacology is: SAGE Publications, USA , 2455 Teller Road, Thousand Oaks, CA 91320, USA.
Keywords for this news article include: Kinase, Princeton, New Jersey, United States, Aminotransferase, Clinical Research, Enzymes and Coenzymes, North and Central America, Clinical Trials and Studies.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC