NCT02253745

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Vernalis (R&D) Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2014-10-01
• Last updated: 2016-06-03

Locations

1 site across 1 country: United States