NCT02286817

Phase I Single Dose, Open-Label Pharmacokinetic Study and Single-Blind, Placebo-Controlled Dose Escalation Study of NFC-1 in Adolescents With Attention-Deficit Hyperactivity Disorder

Phase I Single Dose, Open-label, Pharmacokinetic Study Followed by Single-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Plasma Concentration Profiles, and Targeted Efficacy of NFC-1 in Adolescents (12-17 Years of Age) With Attention-Deficit Hyperactivity Disorder and Genetic Disruption Impacting Metabotropic Glutamate Receptor Genes (NFC1-GREAT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for the effect of NFC-1 on ADHD severity and global functioning during and following four weeks of continuous treatment. Exploratory analyses will be performed to assess effect size of specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study will be conducted at a single clinical site, the Jefferson University Hospital PKU (Philadelphia, PA).

Conditions

• Attention-deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	NFC-1	Single-dose, open label administration to assess safety, tolerability, and pharmacokinetics in adolescents with ADHD and continuous daily administration for four weeks with weekly escalation to evaluate safety, tolerability, and impact on ADHD severity.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-05-01
• Completion: 2016-03-01
• First posted: 2014-11-10
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States