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

NCT03006367 | Completed Phase 1 FDA Drug

• 1 other identifier: MDGN-NFC1-ADHD-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (4)

NFC-1 100 mg

EXPERIMENTAL

Single Dose of NFC-1 100 mg

Drug: NFC-1 100 mg

NFC-1 200 mg

EXPERIMENTAL

Single Dose of NFC-1 200 mg

Drug: NFC-1 200 mg

NFC-1 400 mg

EXPERIMENTAL

Single Dose of NFC-1 400 mg

Drug: NFC-1 400 mg

NFC-1 800 mg

EXPERIMENTAL

Single Dose of NFC-1 800 mg

Drug: NFC-1 800 mg

Interventions

NFC-1 100 mg DRUG

Also known as: AEVI-001, MDGN-001

NFC-1 100 mg

NFC-1 200 mg DRUG

Also known as: AEVI-001, MDGN-001

NFC-1 200 mg

NFC-1 400 mg DRUG

Also known as: AEVI-001, MDGN-001

NFC-1 400 mg

NFC-1 800 mg DRUG

Also known as: AEVI-001, MDGN-001

NFC-1 800 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Subject is 6 to 17 years inclusive at the time of consent/assent.
• 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.
• 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.
• 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.
• Subject has the ability to swallow a capsule of investigational product whole.

You may not qualify if:

• 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.
• Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
• Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
• 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.
• 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.
• 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.
• 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.
• Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
• Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study.
• Subject is unwilling to discontinue current ADHD medication to participate in the study.
• Subject has a clinical laboratory abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.

Sponsors & Collaborators

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

Study Sites (3)

Meridien Research, Inc.

Maitland, Florida, 32751, United States

Location

QPS-MRA, LLC (Miami Research Associates)

Miami, Florida, 33143, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Related Publications (2)

• Glessner JT, Khan ME, Chang X, Liu Y, Otieno FG, Lemma M, Slaby I, Hain H, Mentch F, Li J, Kao C, Sleiman PMA, March ME, Connolly J, Hakonarson H. Rare recurrent copy number variations in metabotropic glutamate receptor interacting genes in children with neurodevelopmental disorders. J Neurodev Disord. 2023 Apr 29;15(1):14. doi: 10.1186/s11689-023-09483-z.

  PMID: 37120522 DERIVED

• 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.

  PMID: 35690720 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 30, 2016
• Study Start: January 7, 2017
• Primary Completion: February 26, 2017
• Study Completion: March 6, 2017
• Last Updated: July 6, 2021

Record last verified: 2017-03

Locations

US (3)