Status:
COMPLETED
Study of 9cUAB30 in Healthy Participants
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
No Evidence of Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This research study is looking at 9cUAB30 in healthy participants. Studying samples of blood and urine from healthy participants may help doctors learn more about how 9cUAB30 is used by the body.
Detailed Description
PRIMARY OBJECTIVES: I. To characterize the single-dose pharmacokinetics of 9cUAB30 in healthy volunteers. SECONDARY OBJECTIVES: I. To determine the toxicities of this drug in these participants. II...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy volunteer
- Karnofsky performance status (PS) 70-100% (ECOG PS 0-1)
- WBC ≥ 3,000/mm³
- Platelet count ≥ 100,000mm³
- Hemoglobin \> 10 g/dL
- Bilirubin ≤ 1.4 mg/dL
- AST ≤ 1.5 times normal
- Creatinine normal
- Sodium 135-144 mmol/L
- Potassium 3.2-4.8 mmol/L
- Chloride 85-114 mmol/L
- Bicarbonate \> 11 mEQ/dL
- Fasting triglycerides ≤ 1.5 times upper limit of normal (ULN)
- Fasting cholesterol ≤ 1.5 times ULN
- Not pregnant or nursing
- No nursing during and for 30 days after completion of study treatment
- Negative pregnancy test
- Fertile participants must use effective contraception prior to, during, and for 1 month after completion of study treatment
- No low-dose progesterone only birth control pills
- 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
- Psychiatricillness or social situation that would limit compliance with study requirements
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to retinoids
- No other concurrent investigational agents
- No concurrent lipid-lowering agents
- No concurrent medications that may interact with 9cUAB30 (e.g., St.John's wort, ketoconazole, vitamin A, tetracycline, or oral corticosteroids)
- No other concurrent topical or oral retinoids (e.g., retinol, retinal, tretinoin \[Retin-A\], isotretinoin, alitretinoin, etretinate, acitretin,tazarotene, or bexarotene)
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00896974
Start Date
August 1 2008
End Date
March 1 2010
Last Update
June 18 2015
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792