NCT00896974

Study of 9cUAB30 in Healthy Participants

A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• No Evidence of Disease

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Retinoid 9cUAB30	Given orally

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-05-12
• Last updated: 2015-06-18

Locations

1 site across 1 country: United States