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.

Study Overview

• Status: Completed
• Conditions: No Evidence of Disease
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Retinoid 9cUAB30

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I; Participants receive a single dose of oral 9cUAB30 on day 1.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Pharmacological Study; Correlative studies; Drug: Retinoid 9cUAB30; Given orally; Other Names: 9cUAB30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single dose pharmacokinetics of 9cUAB30	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.	0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	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.	Up to 30 days

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Howard Bailey, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (ESTIMATE): May 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NCI-2009-00907 (REGISTRY: CTRP (Clinical Trial Reporting Program)); P30CA014520 (U.S. NIH Grant/Contract); N01CN35153 (U.S. NIH Grant/Contract); CO06901; CDR0000610174; WCCC-CO06901 (OTHER: University of Wisconsin Hospital and Clinics); UWI06-8-03 (OTHER: DCP)