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

NCT ID: NCT02253745

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo:V81444

Placebo followed by a 7 day washout then V81444

Group Type: EXPERIMENTAL

V81444

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

V81444:placebo

V81444 followed by a 7 day washout then Placebo

Group Type: EXPERIMENTAL

V81444

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

V81444

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vernalis (R&D) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Vince, MD

Role: PRINCIPAL_INVESTIGATOR

VACR

Locations

Vince and Associates Clinical Research

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

V81444-1CNS-01

Identifier Type: -

Identifier Source: org_study_id