Study of 9cUAB30 in Healthy Participants

No Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896974
• Other study ID #: NCI-2009-00907
• Secondary ID: NCI-2009-00907CO
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2009
• Last updated: June 17, 2015
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• No Evidence of Disease

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Correlative studies

Drug:
• Retinoid 9cUAB30
Given orally

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes