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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.
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Inclusion criteria
Subjects must:
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
In the 2 calendar months before study drug administration
In the calendar month prior to screening
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.
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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