*Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, and KU-Wichita Clinical Trials Unit
†Janssen Pharmceutical Companies of Johnson & Johnson, Titusville, NJ
Dr Preskorn maintains a website at www.preskorn.com where readers can access previous columns and other publications
Material in this column is adapted with permission from the chapter, “Phase I Trials: From Traditional to Newer Approaches”, by Matthew Macaluso, DO, Michael Krams, MD, PhD, and Sheldon H. Preskorn, MD, in Kalali A, ed. Essential CNS Drug Development. Cambridge University Press, in press.
Disclosure statement: Dr Macaluso has conducted clinical trial research as principal investigator funded by Abbott, Envivo, Evotec, Lilly, Naurex, Pfizer/Wyeth, Takeda, and Targacept. Within the last 12 months, Dr Preskorn, as chief science officer of the KU-Wichita Clinical Trials Unit and, in many cases, as principal investigator, has received grants/research support from or has served as a consultant for, on the advisory board, or on the speakers bureau for the following entities: Abbott, Biovail, Boehringer Ingelheim, Bristol-Myers-Squibb, Eisai, Eli Lilly, Evotec, Ipsen, Johnson & Johnson, Link Medicine, Merck, NovaDel Pharma, Naurex, Orexigen, Pfizer, Prexa, Psycho-genetics, Sunovion, Takeda, and Targacept.
*Most drugs produce their beneficial and adverse effects by altering the functional status of a regulatory protein. Target modulation could, for example, involve a drug acting as an agonist, antagonist, or inverse agonist at a specific receptor. Effective target modulation means having the effect at the target (e.g., agonism or antagonism) necessary to produce the desired clinical effect with minimal adverse effects
