NCT01505907Unknown1 期
Phase I, Randomized, Double-Blind, Placebo Controlled, Dose Escalation,Single Dose, Safety, Tolerance, and Pharmacokinetic Study of CXB909 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Pharmacokinetic Parameters
研究概览
简要总结
The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, 18 to 50 years of age.
- •Able to read, understand, and provide written/dated informed consent before screening in the study, and must be willing to comply with all study procedures.
- •In good general health as ascertained by thorough medical history, physical examination (PE)including measurement of supine and standing vital signs, clinical laboratory studies, and 12-lead electrocardiogram (EKG).
- •Body Mass Index (BMI) > 21 and <
- •Willing and able to be confined to the clinical research unit as required by the protocol.
排除标准
- •Presence of a significant acute or chronic medical disorder that might complicate evaluation of the study drug such as:
- •Any cardiovascular or cardiac condition.
- •Supine SBP≥145 mmHg and/or DBP ≥90 mmHg at Screening.
- •Diabetes mellitus.
- •Malignancy and/or chemotherapy within two years of screening, other than basal cell carcinoma. Malignancies more than two years prior may not preclude participation; however, must be reviewed on a case-by-case basis by the CeNeRx BioPharma, Inc., medical monitor.
- •Known or suspected hypersensitivity to CXB
- •Any gastrointestinal disease or digestive disorder, neurological, pulmonary, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder.
- •Current or past psychiatric illness.
- •Use of any prescription medications within 14 days of study drug administration.
- •Use of any over-the-counter (OTC) medication within seven days of study drug administration (including herbal remedies).
- •History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,within the past 12 months.
- •Current use of tobacco products or any nicotine-containing products (e.g., gum, patch)for the prior three months.
- •Consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing on Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, and grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos).
- •Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or confound interpretation of safety data.
- •A clinically significant clinical laboratory or EKG abnormality at screening; includes any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphate (ALP) >2.0 x the upper limit of normal (ULN); total bilirubin >1.5 x the ULN;serum creatinine >1.5 x the ULN; blood urea nitrogen (BUN) >1.5 x the ULN; and thyroid stimulating hormone (TSH) and/or free thyroxine (T4) outside of the normal limits.
- •Test positive for: Urine cannabinoids, cocaine, amphetamines, barbiturates, opiates or benzodiazepines, serum alcohol, hepatitis B or C, or nicotine use.
- •Participation in a clinical investigation within the last 45 days of screening.
- •Any other condition which, in the investigator's opinion, may place the subject at greater than normal risk of developing complications.
- •Donation of any blood product (one pint or greater) within the previous eight weeks of screening.
- •Planning to donate any blood product within eight weeks of end of study.
研究组 & 干预措施
CXB909 15mg
Experimental
CXB909 15mg
干预措施: CXB909 (Drug)
CXB909 30mg
Experimental
干预措施: CXB909 (Drug)
CXB909 60mg
Experimental
干预措施: CXB909 (Drug)
CXB909 120mg
Experimental
Dose
干预措施: CXB909 (Drug)
CXB909 250mg
Experimental
干预措施: CXB909 (Drug)
结局指标
主要结局
Pharmacokinetic Parameters
时间窗: 1 Week
The PK parameters to be determined will include: Tmax, t1/2, Cmax, AUClast, AUCinf, Vd/F and CL/F.
次要结局
- Safety(1 Week)
研究者
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