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drugset / Trial / NCT00890292

A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of JNJ-31001074 in Pediatric Patients (12-17 Years) With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00890292 ↗

Phase 1 Completed 18 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Non-randomizedSingle-groupOpen-labelBasic science

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in patients 12-17 years old with attention deficit hyperactivity disorder (ADHD).

Timeline

Start
2009-05
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject bavisant Small molecule 0.015 mg/kg Oral
Subject bavisant Small molecule 0.045 mg/kg Oral
Subject bavisant Small molecule 0.15 mg/kg Oral

Indications

attention deficit-hyperactivity disorder