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

V

Vernalis Therapeutics

Status and phase

Completed
Phase 2
Phase 1

Conditions

ADHD

Treatments

Drug: V81444
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02253745
V81444-1CNS-01

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

  • 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
  • been exposed to any new investigational agent

In the calendar month prior to screening

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

31 participants in 2 patient groups

Placebo:V81444
Experimental group
Description:
Placebo followed by a 7 day washout then V81444
Treatment:
Drug: Placebo
Drug: V81444
V81444:placebo
Experimental group
Description:
V81444 followed by a 7 day washout then Placebo
Treatment:
Drug: Placebo
Drug: V81444

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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