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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Thomas Jefferson University, Clinical Research Unit
Philadelphia, Pennsylvania, United States
Assessing the safety and tolerability of NFC-1 at each dose level based on assessment of adverse events and other safety measurements including vital signs, electrocardiogram, laboratory safety tests.
Time frame: 24 hours
Profile pharmacokinetics of NFC-1 in adolescents when administered orally as single dose.
Time frame: 24 hours
Assessing the safety and tolerability of NFC-1 during 4 weeks of continuous daily administration based on assessment of adverse events and other safety measurements including vital signs, electrocardiogram, laboratory safety tests.
Time frame: 1-4 weeks
The change in Vanderbilt scores during and following 4-week treatment with NFC-1
Time frame: 1-4 weeks
The change in Actigraphy scores during and following 4-week treatment with NFC-1
Time frame: 1-4 weeks
The change in Quotient ADHD test scores during and following 4-week treatment with NFC-1
Time frame: 1-4 weeks
The change in PERMP-MATH test scores during and following 4-week treatment with NFC-1
Time frame: 1-4 weeks
The change in Clinical Global Impressions Severity/Improvement scores during and following 4-week treatment with NFC-1
Time frame: 1-4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.