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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006367
• Other study ID #: MDGN-NFC1-ADHD-101
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2017
• Est. completion date: March 6, 2017

Study information

• Verified date: March 2017
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 6, 2017
• Est. primary completion date: February 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• NFC-1 100 mg

• NFC-1 200 mg

• NFC-1 400 mg

• NFC-1 800 mg

Locations

Country	Name	City	State
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Meridien Research, Inc.	Maitland	Florida
United States	QPS-MRA, LLC (Miami Research Associates)	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aevi Genomic Medicine, LLC, a Cerecor company

Country where clinical trial is conducted

United States, 

Outcome

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