Study of 9cUAB30 in Healthy Participants
|No Evidence of Disease||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Retinoid 9cUAB30||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics|
- 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.
- 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.
|Study Start Date:||August 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesDrug: Retinoid 9cUAB30
Other Name: 9cUAB30
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896974
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Howard Bailey||University of Wisconsin, Madison|