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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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ADHD

Intervention / Treatment
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* Drug: V81444
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo:V81444<br>Placebo followed by a 7 day washout then V81444 | Drug: V81444<br>* V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14<br>Drug: Placebo<br>* Capsules to match V81444 twice daily for 13 days and once on Day 14<br>|
| Experimental: V81444:placebo<br>V81444 followed by a 7 day washout then Placebo | Drug: V81444<br>* V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14<br>Drug: Placebo<br>* Capsules to match V81444 twice daily for 13 days and once on Day 14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-RS | The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERM-P | The average of the on-treatment total post-dose PERM-P scores for each treatment assessment day during the randomized treatment period will be calculated for each individual. | 5 weeks | 
| Clinical Global Impression (CGI) | The CGI scores will be summarised using frequency counts and percentages. | 5 weeks | 
| Safety and Tolerability | Parameters for evaluation of safety and tolerability: Adverse events, Clinical laboratory safety tests, Physical examination, Vital signs, 12-lead ECG, Telemetry, EGD findings, CSSRS, LSEQ | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention Deficit/ Hyperactivity Disorder