Clinical trial NCT00896974: Study of 9cUAB30 in Healthy Participants
Official title: A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: No Evidence of Disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Single dose pharmacokinetics of 9cUAB30
timeFrame: 0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8
Secondary outcomes:
measure: Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Howard Bailey
role: PRINCIPAL_INVESTIGATOR
References: