A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
18 Years
65 Years
Both
Healthy, no Evidence of Disease
Trial Information
A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
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.
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Single dose pharmacokinetics of 9cUAB30
Outcome Description:
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.
Outcome Time Frame:
0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8
Safety Issue:
No
Principal Investigator
Howard Bailey
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin Hospital and Clinics
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00907
NCT ID:
NCT00896974
Start Date:
August 2008
Completion Date:
Related Keywords:
- Healthy, no Evidence of Disease
Name | Location |
|---|---|
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
