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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: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Healthy, no Evidence of Disease
 Drug: retinoid 9cUAB30
Other: high performance liquid chromatography
Other: pharmacological study

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: August 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
 Drug: retinoid 9cUAB30
Given orally
Other: high performance liquid chromatography
Other Name: HPLC
Other: pharmacological study
Other Name: pharmacological studies

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896974

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Howard Bailey University of Wisconsin Hospital and Clinics
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00896974     History of Changes
Other Study ID Numbers: NCI-2009-00907, WCCC-CO06901, CDR0000610174
Study First Received: May 9, 2009
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013