NCT03203499已完成1 期
A Phase 1b, Proof of Concept, Dose-Ranging Study to Evaluate the Safety of the Coadministration of Ascending Doses of ANS-6637 and Ethanol in Healthy Male Moderate Drinkers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adults, between 21 and 45 years of age, inclusive.
- •Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening).
- •Resting semisupine vital signs at screening and each clinic admission within the following ranges:
- •Systolic blood pressure 90 to 140 mmHg
- •Diastolic blood pressure of 50 to 90 mmHg
- •Heart rate of 40 to 90 beats per minute (bpm)
- •Current alcohol users who are self-reported moderate drinkers, defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least 1 occasion in the 30 days prior to screening. One standard alcoholic drink (14 grams of EtOH) is equivalent to 43 mL (1.5 oz) hard liquor, 142 mL (5 oz) wine or 341 mL (12 oz) beer.
排除标准
- •Drug or alcohol dependence within the 12 months prior to screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
- •Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
- •Current or prior diagnosis of any condition where alcohol consumption is contraindicated, including, but not limited to, hypertriglyceridemia, pancreatitis, liver disease, porphyria, and/or congestive heart failure, that is clinically relevant, as judged by the investigator or designee.
- •Positive urine drug test for EtOH, cocaine, oxycodone and other opioids, amphetamines, benzodiazepines and/or cannabinoids at clinic admission. Positive results may be repeated and/or subjects rescheduled at the investigator's or designee's discretion.
研究组 & 干预措施
ANS-6637
Experimental
Single ascending doses of ANS-6637 administered orally
干预措施: ANS-6637 Oral Tablet (Drug)
Placebo
Placebo Comparator
Placebo administered orally
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Up to 36 hours postdose
次要结局
- Maximum observed serum concentration (Cmax)(Up to 48 hours postdose)
- Time to maximum observed serum concentration (Tmax)(Up to 48 hours postdose)
- Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)(Up to 48 hours postdose)
- Ethanol Consumption(Up to 6 hours postdose)
- Modified 5-Item Drug Effects Questionnaire (mDEQ-5)(Up to 6 hours postdose)
研究者
研究点 (1)
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