Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)

Inclusion criteria

• 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

Exclusion criteria

• 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.