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

Phase 1

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: NFC-1 800 mg; Drug: NFC-1 100 mg; Drug: NFC-1 200 mg; Drug: NFC-1 400 mg

• Registration Number: NCT03006367
• Lead Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-30
• Study Start: 2017-01-07
• Primary Completion: 2017-02-26
• Status Verified: 2017-03
• Study Completion: 2017-03-06
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NFC-1 800 mg	NFC-1 800 mg	Single Dose of NFC-1 800 mg
NFC-1 100 mg	NFC-1 100 mg	Single Dose of NFC-1 100 mg
NFC-1 200 mg	NFC-1 200 mg	Single Dose of NFC-1 200 mg
NFC-1 400 mg	NFC-1 400 mg	Single Dose of NFC-1 400 mg

Primary Outcome Measures

Name	Time	Method
Terminal Half Life (T½ ) of NFC-1	28 hours of sample collections
Area under the plasma drug concentration-time curve (AUC0-24h)	24 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
Maximum Observed Plasma Concentration (Cmax)	28 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
Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1	28 hours of sample collections

Trial Locations

Locations (3)

Meridien Research, Inc.; 🇺🇸 Maitland, Florida, United States

QPS-MRA, LLC (Miami Research Associates); 🇺🇸 Miami, Florida, United States

Center for Psychiatry and Behavioral Medicine; 🇺🇸 Las Vegas, Nevada, United States