Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT00100958
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2005-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Sponsor:
University of Kansas
Organization:
Study Overview
Official Title:
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.
Detailed Description:
OBJECTIVES:
Primary
* Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
* Determine the safety and tolerability of this drug in these participants.
* Determine the pharmacokinetics of this drug in these participants.
Secondary
* Determine the effects of this drug on selected markers of sexual function in these participants.
* Determine the effects of this drug on markers of susceptibility to cancer in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.
* Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
* Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.
Participants are followed on days 2, 3, and 6.
PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.
Primary
* Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
* Determine the safety and tolerability of this drug in these participants.
* Determine the pharmacokinetics of this drug in these participants.
Secondary
* Determine the effects of this drug on selected markers of sexual function in these participants.
* Determine the effects of this drug on markers of susceptibility to cancer in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.
* Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
* Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.
Participants are followed on days 2, 3, and 6.
PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.
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 |
|---|---|---|---|---|
| KUMC-HSC-9139-2 | None | None | View |