Study of 9cUAB30 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896974
First received: May 9, 2009
Last updated: October 7, 2014
Last verified: February 2014

May 9, 2009
October 7, 2014
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 ] [ Designated as safety issue: No ]
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.
Pharmacokinetics [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00896974 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: Yes ]
  • Correlation of pharmacokinetics with toxicity [ Designated as safety issue: No ]
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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy, no Evidence of Disease
  • Drug: retinoid 9cUAB30
    Given orally
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
Interventions:
  • Drug: retinoid 9cUAB30
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
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)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00896974
NCI-2009-00907, NCI-2009-00907, CO06901, CDR0000610174, WCCC-CO06901, UWI06-8-03, P30CA014520, N01CN35153
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Howard Bailey University of Wisconsin Hospital and Clinics
National Cancer Institute (NCI)
February 2014

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