NCT00287833

Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	placebo	Given orally
DRUG	Bowman-Birk inhibitor concentrate	Given orally

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-04-01
• First posted: 2006-02-07
• Last updated: 2013-05-03

Locations

1 site across 1 country: United States