Study of 9cUAB30 in Healthy Participants

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

No Evidence of Disease

Treatments

Other: Pharmacological Study

Other: Laboratory Biomarker Analysis

Drug: Retinoid 9cUAB30

Study type

Interventional

Funder types

NIH

Identifiers

NCT00896974

WCCC-CO06901 (Other Identifier)

NCI-2009-00907 (Registry Identifier)

CO06901

N01CN35153 (U.S. NIH Grant/Contract)

P30CA014520 (U.S. NIH Grant/Contract)

UWI06-8-03 (Other Identifier)

CDR0000610174

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)