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

ADHD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253745
• Other study ID #: V81444-1CNS-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 26, 2014
• Last updated: December 9, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: Vernalis (R&D) Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Drug:
• V81444
V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14
• Placebo
Capsules to match V81444 twice daily for 13 days and once on Day 14

Locations

Country	Name	City	State
United States	Vince and Associates Clinical Research	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vernalis (R&D) Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Clinical Global Impression (CGI)	The CGI scores will be summarised using frequency counts and percentages.	5 weeks	No
Secondary	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	Yes