NCT01336387

Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers

A Randomized, Double-Blind, Single-dose and Multi-dose Study of the Novel Retinoid, 9cUAB30, to Determine Pharmacokinetics and Safety

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This randomized phase I trial studies the side effects and the best dose of retinoid 9cUAB30 in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of retinoid 9cUAB30 may keep cancer from forming.

Detailed description

PRIMARY OBJECTIVES: I. The primary objective is to determine the toxicities and recommended phase II dose of 9cUAB30. The co- primary objective is to characterize the urine and plasma single dose and steady state pharmacokinetics of 9cUAB30 in normal volunteers. SECONDARY OBJECTIVES: I. To correlate the pharmacokinetics of 9cUAB30 with toxicity. II. To compare observed toxicity between placebo controls and each dose level. III. To assess for any change in single dose PK after repeat dosing (Day 1 vs. Day 36). IV. To assess the following potential biomarkers of UAB30: * Telomerase activity (measurement of telomeric repeats) in PBMCs. * Gene expression of DNA methyltransferase in PBMCs. * Gene expression of CYP2B6 in PBMCs. OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms. ARM I: Participants receive retinoid 9cUAB30\* orally (PO) on days 1-28. ARM II: Participants receive placebo\* PO on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity. \*NOTE: Participants receive doses on days 8, 15, 22 and 29 after they have fasted for 12 hours. After completion of study treatment, patients are followed up on days 7 and 30.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	retinoid 9cUAB30	Given PO
OTHER	placebo	Given PO
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	cancer prevention	Disease prevention

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-04-15
• Last updated: 2014-10-09

Locations

1 site across 1 country: United States