A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
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.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
University of Wisconsin Hospital and Clinics
United States: Food and Drug Administration
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|