Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD

An Open-label, Single Ascending Dose, Pharmacokinetic and Tolerability Study of NFC-1 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder

This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: NFC-1 100 mg; Drug: NFC-1 200 mg; Drug: NFC-1 400 mg; Drug: NFC-1 800 mg

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Meridien Research, Inc.
    • Miami, Florida, United States, 33143
      • QPS-MRA, LLC (Miami research Associates)
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center For Psychiatry And Behavioral Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject and parent/legally authorized representative (LAR) are able to speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
2. Subject is 6 to 17 years inclusive at the time of consent/assent.
3. Subject is male, female of non-childbearing potential or non-pregnant, non-lactating female of childbearing potential who agrees to comply with any applicable contraceptive requirements 2 weeks prior to administration of IP and throughout the study.
4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International Neuropsychiatric Interview.
5. Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination.
6. Subject has the ability to swallow a capsule of investigational product whole.

Exclusion Criteria:

1. Subject has a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD.
2. Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
3. Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
4. Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
5. Subject has used an investigational product, been enrolled in a clinical study including vaccines, or had any changes in eating habits, within 30 days prior to the first dose of investigational product.
6. Subject has a positive screen for alcohol or drugs of abuse, or a positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV antibody screen.
7. Subject previously was an adolescent (12-17) who was either a screen failure, or enrolled or participated in this study or another NFC1 clinical study.
8. Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
9. Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study.
10. Subject is unwilling to discontinue current ADHD medication to participate in the study.
11. Subject has a clinical laboratory abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NFC-1 100 mg; Single Dose of NFC-1 100 mg	Drug: NFC-1 100 mg; Other Names: AEVI-001; MDGN-001
Experimental: NFC-1 200 mg; Single Dose of NFC-1 200 mg	Drug: NFC-1 200 mg; Other Names: AEVI-001; MDGN-001
Experimental: NFC-1 400 mg; Single Dose of NFC-1 400 mg	Drug: NFC-1 400 mg; Other Names: AEVI-001; MDGN-001
Experimental: NFC-1 800 mg; Single Dose of NFC-1 800 mg	Drug: NFC-1 800 mg; Other Names: AEVI-001; MDGN-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma drug concentration-time curve (AUC0-24h)	24 hours of sample collections
Area under the plasma drug concentration-time curve (AUC0-inf)	28 hours of sample collections
Area under the plasma drug concentration-time curve (AUClast)	28 hours of sample collections
Terminal Half Life (T½ ) of NFC-1	28 hours of sample collections
Maximum Observed Plasma Concentration (Cmax)	28 hours of sample collections
Time to Maximum Observed Plasma Concentration (Tmax)	28 hours of sample collections
Apparent first order elimination rate constant (kel)	28 hours of sample collections
Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1	28 hours of sample collections
Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1	28 hours of sample collections

Collaborators and Investigators

• Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company

Publications and helpful links

General Publications

• Slaby I, Hain HS, Abrams D, Mentch FD, Glessner JT, Sleiman PMA, Hakonarson H. An electronic health record (EHR) phenotype algorithm to identify patients with attention deficit hyperactivity disorders (ADHD) and psychiatric comorbidities. J Neurodev Disord. 2022 Jun 11;14(1):37. doi: 10.1186/s11689-022-09447-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2017
• Primary Completion (Actual): February 26, 2017
• Study Completion (Actual): March 6, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: MDGN-NFC1-ADHD-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No