Study of 9cUAB30 in Healthy Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics

Conditions
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No Evidence of Disease

Intervention / Treatment
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* Other: Laboratory Biomarker Analysis
* Other: Pharmacological Study
* Drug: Retinoid 9cUAB30


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Participants receive a single dose of oral 9cUAB30 on day 1. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Pharmacological Study<br>* Correlative studies<br>Drug: Retinoid 9cUAB30<br>* Given orally<br>* Other names: 9cUAB30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose pharmacokinetics of 9cUAB30 | Scatterplots will be used to explore possible associations. Jonckheere-Terpstra trend test will be performed to determine the significance of the association between increasing dose level and each of the pharmacokinetic parameters. A Spearman rank correlation analysis will be performed to determine the relationship between actual dose administered and the pharmacokinetic parameters. Additionally, logistic regression analyses will be performed to correlate PK parameters with toxicity. | 0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Patient toxicity will be summarized in several ways; the presence or absence of any toxicities, worst CTCAE grade, and strongest investigator-defined relationship will all be examined and characterized by dose. The different pharmacokinetic measures will be correlated with toxicity measures with polyserial correlation, a method for estimating the correlation between a continuous variable and an ordinal variable whose underlying distribution is continuous. | Up to 30 days |