Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT00784394
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2008-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diindolylmethane in Preventing Cancer in Healthy Volunteers
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)
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 phase I clinical trial studies the side effects and best dose of diindolylmethane in preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people who eat a chemical that is normally found in vegetables, including cabbage, broccoli, Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development of cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are safe and well- tolerated.
II. To determine the pharmacokinetics of these single oral doses of DIM.
OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.
ARM II: Participants receive a single dose of placebo orally (PO) on day 1.
After completion of study treatment, participants are followed up on days 2, 3, and 6.
I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are safe and well- tolerated.
II. To determine the pharmacokinetics of these single oral doses of DIM.
OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.
ARM II: Participants receive a single dose of placebo orally (PO) on day 1.
After completion of study treatment, participants are followed up on days 2, 3, and 6.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-00523 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| NO1-CN-35008-38 | None | None | View | |
| CDR0000617334 | None | None | View | |
| KUMC-HSC-9139 | OTHER | University of Kansas Medical Center | View | |
| N01-CN-35008-1 | OTHER | DCP | View | |
| N01CN35008 | NIH | None | https://reporter.nih.gov/quic… | View |