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

NCT02253745 | Completed Phase 1

• 1 other identifier: V81444-1CNS-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; Attention Deficit/ Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PERM-P

  5 weeks

• Clinical Global Impression (CGI)

  5 weeks

• Safety and Tolerability

  11 weeks

Study Arms (2)

Placebo:V81444

EXPERIMENTAL

Placebo followed by a 7 day washout then V81444

Drug: V81444; Drug: Placebo

V81444:placebo

EXPERIMENTAL

V81444 followed by a 7 day washout then Placebo

Drug: V81444; Drug: Placebo

Interventions

V81444 DRUG

V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14

Placebo:V81444; V81444:placebo

Placebo DRUG

Capsules to match V81444 twice daily for 13 days and once on Day 14

Placebo:V81444; V81444:placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead

Study Sites (1)

Vince and Associates Clinical Research

Kansas City, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Bradley Vince, MD

  VACR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 1, 2014
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 3, 2016

Record last verified: 2015-12

Locations

US (1)