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Completed

NCT Number: NCT03006367

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Meridien Research, Inc., Maitland, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NFC-1 100 mg

Drug

Other names: AEVI-001, MDGN-001

NFC-1 200 mg

Drug

Other names: AEVI-001, MDGN-001

NFC-1 400 mg

Drug

Other names: AEVI-001, MDGN-001

NFC-1 800 mg

Drug

Other names: AEVI-001, MDGN-001

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2016
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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