Task I: Single-dose Pharmacokinetic Study The Contractor shall develop a single-dose phase 1 clinical protocol for a variety of agents to evaluate the parameters of drug absorption, plasma concentration-time profiles, distribution (in relevant tissues, where feasible), excretion and toxicity. Task II: Multiple-dose Safety and Pharmacokinetic Study The Contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for the chemopreventive agents to evaluate the parameters of safety and toxicity and of steady state pharmacokinetics. In addition, investigations of pharmacological and/or cancer surrogate endpoint biomarker modulation may be undertaken. Protocol activation for Task I and Task II will occur following IRB and FDA approval and the receipt of all chemopreventive drugs from the NCI review, and subunit a finalized protocol for IRB approval. The Contractor shall prepare all materials necessary for FDA approval. The NCI will submit the protocol to the FDA and will hod the IND.
| Pop, Elena A; Fischer, Leslie M; Coan, April D et al. (2008) Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis, and estrogenic outcomes in healthy postmenopausal women: a phase I clinical trial. Menopause 15:684-92 |
| Niculescu, Mihai D; Pop, Elena A; Fischer, Leslie M et al. (2007) Dietary isoflavones differentially induce gene expression changes in lymphocytes from postmenopausal women who form equol as compared with those who do not. J Nutr Biochem 18:380-90 |
| Bloedon, LeAnne T; Jeffcoat, A Robert; Lopaczynski, Wlodek et al. (2002) Safety and pharmacokinetics of purified soy isoflavones: single-dose administration to postmenopausal women. Am J Clin Nutr 76:1126-37 |
