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Study of 9cUAB30 in Healthy Participants

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00896974
Enrollment
15
Registered
2009-05-12
Start date
2008-08-31
Completion date
2010-03-31
Last updated
2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Evidence of Disease

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. 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.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERPharmacological Study

Correlative studies

Given orally

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Single dose pharmacokinetics of 9cUAB300, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8Scatterplots 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.

Secondary

MeasureTime frameDescription
Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0Up to 30 daysPatient 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026