Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00679094
Brief Summary:
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Detailed Description:
OBJECTIVES:
I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants.
II. Determine the appropriate dose range and doses to be used in a subsequent phase I multiple-dose BBIC study that will be based upon the data gathered from this phase I single-dose study.
III. Characterize the pharmacokinetics of single-dose BBIC.
OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC). Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo or BBIC.
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
Participants undergo blood and urine sample collection periodically for pharmacokinetic studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure concentrations of BBIC and its metabolites in serum and urine.
After completion of study treatment, participants are followed once weekly for 4 weeks.
Study:
NCT00679094
Study Brief:
Protocol Section:
NCT00679094