Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-03 @ 7:58 AM
Study NCT ID:
NCT00679094
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bowman-Birk Inhibitor Concentrate in Healthy Men
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00865 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000595863 | None | None | View | |
| UPCC-N01-CN-25118-2 | None | None | View | |
| UPCC-805938 | None | None | View | |
| UPCC-805938 | OTHER | Abramson Cancer Center of The University of Pennsylvania | View | |
| N01-CN-25118-2 | OTHER | DCP | View | |
| P30CA016520 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CN25118 | OTHER | US NIH Grant/Contract Award Number | View |