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

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.