A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Single dose pharmacokinetics of 9cUAB30
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
干预措施: Pharmacological Study (Other)
Arm I
Participants receive a single dose of oral 9cUAB30 on day 1.
干预措施: Retinoid 9cUAB30 (Drug)
结局指标
主要结局
Single dose pharmacokinetics of 9cUAB30
时间窗: 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.
次要结局
- Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0(Up to 30 days)