Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287833
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2006-02-06
Brief Title:
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2013-05
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000429594 | None | None | None |
| UPCC-706366 | None | None | None |
| N01-CN-25118 | None | None | None |