Subjects with proliferative thyroid disease

Proliferative Thyroid Disease

300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days

Diindolylmethane (DIM)

The New York Eye & Ear Infirmary

DIM as a Treatment for Thyroid Disease

Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol

Stimpson P. Schantz

Principal Investigator

Participants receive a single dose of diindolylmethane PO on day 1.

Participants receive a single dose of placebo orally (PO) on day 1.

Healthy, no Evidence of Disease

diindolylmethane

placebo

pharmacological study

laboratory biomarker analysis

quality-of-life assessment

University of Kansas Medical Center

Diindolylmethane in Preventing Cancer in Healthy Volunteers

Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)

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.

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.

diindolylmethane/kupus

DIM as a Treatment for Thyroid Disease

Diindolylmethane in Preventing Cancer in Healthy Volunteers

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