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)

Vernalis (R&D) Ltd1 site in 1 country31 target enrollmentJuly 2013

ConditionsADHD

InterventionsV81444 Placebo

DrugsV81444 Placebo

Overview

Phase: Phase 1
Intervention: V81444
Conditions: ADHD
Sponsor: Vernalis (R&D) Ltd
Enrollment: 31
Locations: 1
Primary Endpoint: ADHD-RS
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

April 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Vernalis (R&D) Ltd

Responsible Party

Sponsor

Eligibility Criteria

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