Studying Different Formulations of SR13668 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy, no Evidence of Disease

In brief

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.

Key facts

Study ID

NCT00896207

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2009-06-01

Expected to finish

2010-03-01

Last updated by the study team

2014-10-08

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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