Studying Different Formulations of SR13668 in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Healthy volunteer

• ECOG performance status 0

• Leukocyte count ≥ 3,000/mm^3

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin normal

• Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)

• ALT ≤ 1.5 times ULN

• Direct bilirubin ≤ 1.5 times ULN

• Sodium ≤ 1.5 times ULN

• Potassium ≤ 1.5 times ULN

• Creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 30 mL/min

• Fasting blood glucose normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile participants must use effective barrier contraception

• Able and willing to fast overnight prior to study drug administration AND consume a high-fat meal on the day of study drug administration

• Willing to provide required blood and urine samples AND stay all day and overnight in the Clinical Research Unit

• Willing to abstain from alcoholic beverages and caffeine for ≥ 24 hours prior to study drug administration and until all blood and urine samples have been collected

• No cancer within the past 3 years except for nonmelanoma skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix

• No concurrent uncontrolled illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Severe chronic obstructive pulmonary disease requiring supplemental oxygen

• Hypertension that is difficult to control

• Psychiatric illness or social situation that would limit compliance with study requirements

• No diabetes mellitus

• No other condition that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications (e.g., inflammatory bowel disease)

• No history of allergic-type reactions, including asthma and urticaria, or other intolerance to chemical compounds similar to the active study agent, indole-3-carbinol, or cruciferous vegetables (e.g., cabbage, cauliflower, broccoli, kale, and Brussels sprouts)

• More than 6 months since prior investigational agents

• More than 3 months since prior oral contraceptives (including Plan B method of contraception)

• No concurrent hormonal contraception

• More than 14 days since prior and no concurrent anticoagulant or antiplatelet medications

• More than 7 days since prior and no concurrent daily medications or nutritional supplements

• No prior gastrectomy that may, in the investigator's opinion, interfere with ingestion or absorption of oral medications

• No other concurrent medications