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

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)

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: V81444; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66212
      • Vince and Associates Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must:

  1. Be male or female subjects aged 18 to 50 years inclusive
  2. 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:
  3. Have a body mass index (BMI) between 19 and 32 kg/m2 inclusive
  4. Be willing and able to comply with the requirements of the entire study
  5. Be able to read and understand English
  6. Give written informed consent

Exclusion Criteria:

1. Have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
2. Have any other significant psychiatric disorder, as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
3. 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
4. Have a history or evidence of clinically significant GI disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis
5. Have had any previous gastric surgery and/or bariatric procedure
6. Have any known malformations that would make EGD difficult or unsafe
7. Have taken any prohibited concomitant medication
8. 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
9. Have abused drugs in the 12 months before study drug administration

10. 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

11. 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

12. In the calendar month prior to screening

    • used non-steroidal anti-inflammatory drugs regularly
    • had a new tattoo or body piercing
13. Have any clinically relevant abnormal findings at Screening and/or admission
14. Plan to undergo elective procedures/surgery at any time during the study
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vernalis (R&D) Ltd
• Investigators: Principal Investigator: Bradley Vince, MD, VACR

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: ADHD; Attention Deficit/ Hyperactivity Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: V81444-1CNS-01