Study of 9cUAB30 in Healthy Participants

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. To correlate the pharmacokinetics with the toxicity of this drug in these participants.

OUTLINE:

Participants receive a single dose of oral 9cUAB30 on day 1. Blood and urine samples are collected at baseline, periodically on day 1, and then on day 8 for pharmacokinetic studies by high performance liquid chromatography.

After completion of treatment, participants are followed at days 8 and 30.

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)