Study of 9cUAB30 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896974
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

May 9, 2009
May 12, 2009
June 18, 2015
August 2008
March 2010   (Final data collection date for primary outcome measure)
Single dose pharmacokinetics of 9cUAB30 [ Time Frame: 0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8 ]
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.
Complete list of historical versions of study NCT00896974 on Archive Site
Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 30 days ]
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.
  • Toxicity
  • Correlation of pharmacokinetics with toxicity
Not Provided
Not Provided
Study of 9cUAB30 in Healthy Participants
A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
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.


I. To characterize the single-dose pharmacokinetics of 9cUAB30 in healthy volunteers.


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.


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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
No Evidence of Disease
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Pharmacological Study
    Correlative studies
  • Drug: Retinoid 9cUAB30
    Given orally
    Other Name: 9cUAB30
Experimental: Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Drug: Retinoid 9cUAB30
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2010
March 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2009-00907 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
WCCC-CO06901 ( Other Identifier: University of Wisconsin Hospital and Clinics )
UWI06-8-03 ( Other Identifier: DCP )
N01CN35153 ( U.S. NIH Grant/Contract )
P30CA014520 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Howard Bailey University of Wisconsin, Madison
National Cancer Institute (NCI)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP