NCT02253745已完成1 期
A Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Repeat Oral Doses of V81444 in Volunteers With Attention Deficit / Hyperactivity Disorder (ADHD)
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
- 31
- 试验地点
- 1
- 主要终点
- ADHD-RS
研究概览
简要总结
The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •Be male or female subjects aged 18 to 50 years inclusive
- •Meet DSM-IV-TR criteria for a primary diagnosis of ADHD combined, hyperactive-impulsive or predominantly inattentive type; confirmed by a minimum score of 24 on the ADHD-RS with adult prompts:
- •Have a body mass index (BMI) between 19 and 32 kg/m2 inclusive
- •Be willing and able to comply with the requirements of the entire study
- •Be able to read and understand English
- •Give written informed consent
排除标准
- •Have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
- •Have any other significant psychiatric disorder, as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
- •Have known mental impairment defined as an intelligence quotient (IQ) less than 75, or clinical evidence of mental impairment based on the opinion of the Investigator
- •Have a history or evidence of clinically significant GI disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis
- •Have had any previous gastric surgery and/or bariatric procedure
- •Have any known malformations that would make EGD difficult or unsafe
- •Have taken any prohibited concomitant medication
- •Have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo (see Section 7.1) or lidocaine
- •Have abused drugs in the 12 months before study drug administration
- •In the 90 days before study drug administration, on average
- •have smoked more than 5 cigarettes per day
- •have consumed more than 28 units of alcohol per week
- •have consumed more than 500 mg of caffeine per day
- •In the 2 calendar months before study drug administration
- •have donated blood or plasma in excess of 500 mL
- •been exposed to any new investigational agent
- •In the calendar month prior to screening
- •used non-steroidal anti-inflammatory drugs regularly
- •had a new tattoo or body piercing
- •Have any clinically relevant abnormal findings at Screening and/or admission
- •Plan to undergo elective procedures/surgery at any time during the study
- •Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
研究组 & 干预措施
Placebo:V81444
Experimental
Placebo followed by a 7 day washout then V81444
干预措施: V81444 (Drug)
Placebo:V81444
Experimental
Placebo followed by a 7 day washout then V81444
干预措施: Placebo (Drug)
V81444:placebo
Experimental
V81444 followed by a 7 day washout then Placebo
干预措施: V81444 (Drug)
V81444:placebo
Experimental
V81444 followed by a 7 day washout then Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
ADHD-RS
时间窗: 5 weeks
The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
次要结局
- PERM-P(5 weeks)
- Clinical Global Impression (CGI)(5 weeks)
- Safety and Tolerability(11 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study Evaluating the Effects of GLPG3667 Given as an Oral Treatment for 4 Weeks in Adults With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT04594928Galapagos NV30
已完成
3 期
Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety DisorderBipolar DisorderAnxiety DisorderNCT00277654Lindner Center of HOPE111
终止
4 期
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic DisorderPanic DisorderNCT00635531Pfizer's Upjohn has merged with Mylan to form Viatris Inc.16
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese ParticipantsHealthy VolunteersNCT05813717Bristol-Myers Squibb25
已完成
1 期
A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male ParticipantsHealthyNCT02280018Janssen Research & Development, LLC12