- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784394
Diindolylmethane in Preventing Cancer in Healthy Volunteers
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-smokers and non-users of abuse drugs as confirmed by urine cotinine (Accutest NicoMeter Urine Professional strip or equivalent test) and drug screen at visit 1
- Free of acute, unstable, chronic or recurring medical conditions based on history, physical examination, laboratory tests; the laboratory tests to be performed will be: blood serum chemistry screen to include comprehensive metabolic panel (glucose, creatinine, urea nitrogen [blood urea nitrogen (BUN)], sodium, potassium, chloride, calcium, total bilirubin, protein, albumin, globulin, cholesterol and the enzymes alkaline phosphatase, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]) and lipid panel (total, low density lipoprotein [LDL] and high density lipoprotein [HDL] cholesterol and triglycerides); complete blood count including differential and platelet count; prothrombin time; and routine urinalysis; values for laboratory tests must be within the ranges below grade 2 of Common Toxicity Criteria (CTC) and/or as specified below:
- Hemoglobin > 10 g/dL
- Absolute granulocyte count > 1500/ìL
- Creatinine < 2.0 mg/dl
- Albumin > 3.0 g/dl
- Bilirubin < 1.8 mg/dl
- AST < 110 U/l
- ALT < 110 U/l
- Alkaline phosphatase < 300 U/l
- Subjects must weigh +/- 20% of ideal body weight by the Metropolitan Life tables
- Men or women who are strict vegetarians or who eat more than 3 medium servings (1/2 cup each) of cruciferous vegetables per week will be excluded; those who stop ingesting cruciferous vegetables >= 14 days and alcohol >= 7 days before starting DIM and agree to refrain from taking them for the duration of the study will not be excluded; cruciferous vegetables include broccoli, cabbage (including coleslaw), cauliflower, bok-choy, Brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress; participants will be asked to complete a brief diet questionnaire listing these vegetables to assess these criteria; caffeine- and grapefruit-containing foods and beverages are to be avoided for at least 48 hours before visit 2 (DIM dosing)
Exclusion Criteria:
- Subjects with serious drug allergies or other serious intolerance or allergies will be excluded; those with mild seasonal allergies will be accepted
- Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions
- Subjects with a serious acute or chronic illness (diabetes, arthritis, asthma, etc.) or requiring chronic drug therapy, who continuously take supplements or have taken an investigational drug within the past three months
- Subjects who have evidence of an active malignancy or have received chemotherapy, and/or antiestrogen therapy
- Subjects who have a life expectancy of < 12 months
- Subjects who have regularly taken over the past 21 days any concomitant medications, herbal products, dietary supplements or vitamins; women taking oral contraceptives will be accepted; women who are pregnant (positive urine human chorionic gonadotropin [hCG] at visit 2) or lactating will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (diindolylmethane)
Participants receive a single dose of diindolylmethane PO on day 1.
|
Correlative studies
Correlative studies
Other Names:
Ancillary studies
Other Names:
Given PO
Other Names:
|
Placebo Comparator: Arm II (placebo)
Participants receive a single dose of placebo orally (PO) on day 1.
|
Correlative studies
Correlative studies
Other Names:
Ancillary studies
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD), defined as the highest dose at which no grade 2 or higher toxicities are seen
Time Frame: Up to day 6
|
Frequencies and percents will be used to summarize the toxicities seen at each dose level and overall.
Descriptive statistics will be calculated on all variables of interest: frequencies and percentages will be used to summarize categorical variables and medians, and ranges will summarize quantitative variables.
|
Up to day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of diindolylmethane
Time Frame: Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration
|
Pharmacokinetic parameters such as half-life, maximum concentration (Cmax), time of Cmax (Tmax), and area under the concentration-time curve (AUC) will be calculated for all subjects who complete the study.
It is anticipated that a one-compartment elimination model will fit the data.
These parameters will be summarized at each dose and overall with median and ranges.
|
Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aryeh Hurwitz, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2014-00523 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- N01CN35008 (Other Identifier: US NIH Grant/Contract Award Number)
- NO1-CN-35008-38
- CDR0000617334
- KUMC-HSC-9139 (Other Identifier: University of Kansas Medical Center)
- N01-CN-35008-1 (Other Identifier: DCP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy, no Evidence of Disease
-
Cancer Research UKUnknownHealthy, no Evidence of DiseaseUnited Kingdom
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedHealthy, no Evidence of DiseaseUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedHealthy, No Evidence of DiseaseUnited States
-
National Cancer Institute (NCI)CompletedHealthy, no Evidence of DiseaseUnited States
-
National Cancer Institute (NCI)TerminatedHealthy, no Evidence of DiseaseUnited States
-
National Cancer Institute (NCI)CompletedHealthy, no Evidence of DiseaseUnited States
-
National Cancer Institute (NCI)CompletedHealthy, no Evidence of DiseaseUnited States
-
National Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Completed
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States