Bowman-Birk Inhibitor Concentrate in Healthy Men

NCT00679094 | Completed Phase 1

• 7 other identifiers: NCI-2009-00865CDR0000595863UPCC-N01-CN-25118-2UPCC-805938N01-CN-25118-2P30CA016520N01CN25118
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria

  Up to 48 hours

• Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay

  Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.

  Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: Bowman-Birk inhibitor concentrate; Other: placebo; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

Bowman-Birk inhibitor concentrate DRUG

Given orally

Also known as: BBIC

Arm I

placebo OTHER

Given orally

Also known as: PLCB

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
• ECOG performance status 0-2
• WBC ≥ 3,000/uL
• Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
• Platelet count normal
• Hemoglobin normal
• Hematocrit normal
• RBC normal
• Creatinine normal
• Bilirubin normal
• ALT and AST normal
• Amylase and lipase normal
• Glucose normal
• Cholesterol normal
• Triglycerides normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Lilie Lin

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)