Study of 9cUAB30 in Healthy Participants

Phase 1

Completed

• Conditions: No Evidence of Disease
• Interventions: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Retinoid 9cUAB30

• Registration Number: NCT00896974
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-02
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Laboratory Biomarker Analysis	Participants receive a single dose of oral 9cUAB30 on day 1.
Arm I	Pharmacological Study	Participants receive a single dose of oral 9cUAB30 on day 1.
Arm I	Retinoid 9cUAB30	Participants receive a single dose of oral 9cUAB30 on day 1.

Primary Outcome Measures

Name	Time	Method
Single dose pharmacokinetics of 9cUAB30	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.

Secondary Outcome Measures

Name	Time	Method
Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	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.

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States