Study of 9cUAB30 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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No Evidence of Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Participants receive a single dose of oral 9cUAB30 on day 1.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Pharmacological Study

Intervention Type OTHER

Correlative studies

Retinoid 9cUAB30

Intervention Type DRUG

Given orally

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Pharmacological Study

Correlative studies

Intervention Type OTHER

Retinoid 9cUAB30

Given orally

Intervention Type DRUG

Other Intervention Names

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9cUAB30

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes