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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00287833
Brief Summary:
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.
II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these participants.
OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.
After completion of study treatment, participants are followed periodically for 4 weeks.
Study:
NCT00287833
Study Brief:
Protocol Section:
NCT00287833