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

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ClinicalTrials.gov Identifier: NCT03006367
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Aevi Genomic Medicine

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: NFC-1 100 mg Drug: NFC-1 200 mg Drug: NFC-1 400 mg Drug: NFC-1 800 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2017
Actual Primary Completion Date : February 26, 2017
Actual Study Completion Date : March 6, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Area under the plasma drug concentration-time curve (AUC0-24h) [ Time Frame: 24 hours of sample collections ]
  2. Area under the plasma drug concentration-time curve (AUC0-inf) [ Time Frame: 28 hours of sample collections ]
  3. Area under the plasma drug concentration-time curve (AUClast) [ Time Frame: 28 hours of sample collections ]
  4. Terminal Half Life (T½ ) of NFC-1 [ Time Frame: 28 hours of sample collections ]
  5. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 28 hours of sample collections ]
  6. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 28 hours of sample collections ]
  7. Apparent first order elimination rate constant (kel) [ Time Frame: 28 hours of sample collections ]
  8. Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1 [ Time Frame: 28 hours of sample collections ]
  9. Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1 [ Time Frame: 28 hours of sample collections ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006367


Locations
United States, Florida
Meridien Research, Inc.
Maitland, Florida, United States, 32751
QPS-MRA, LLC (Miami Research Associates)
Miami, Florida, United States, 33143
United States, Nevada
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
Aevi Genomic Medicine

Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT03006367     History of Changes
Other Study ID Numbers: MDGN-NFC1-ADHD-101
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms