Atomoxetine PBPK-PD Clinical Study

Inclusion Criteria:

- Males and females 6-18 years of age

- Diagnosis of ADHD.

- It is the intention of the treating physician to begin therapy with atomoxetine (ATX).

- ADHD-medication naïve or willing to undergo a two week wash out period.

- Willing to provide written permission/assent to participate.

Exclusion Criteria:

- • An IQ < 70.

- A diagnosis of Autism Spectrum Disorder.

- Inability or unwillingness to have blood drawn.

- Concurrent therapy with drugs known to inhibit CYP2D6 and unwilling or unable to
undergo a washout period. This includes medications such as fluoxetine,
sertraline, paroxetine, venlafaxine, imipramine, nortriptyline, quinidine,
propafenone, cimetidine, tamoxifen, bupropion, over-the-counter medications
containing diphenhydramine, codeine, tramadol, hydrocodone, or oxycodone.

- Previous treatment with strong CYP2D6 inhibitors, such as fluoxetine or
paroxetine (two month wash-out required), or terbenafine (six month wash-out
required).

- Underlying risk for cardiotoxicity, such as presentation of structural cardiac
abnormalities, cardiomyopathy, or arrhythmias.

- Clinically significant abnormal safety laboratory values as determined by
treating physician

- Presentation of diagnosis that may cause abnormal absorption or gastric emptying,
such as reflux, inflammatory bowel disease, or Crohn's disease.

- For females, a positive urine pregnancy test.

- Previous history of adverse drug reaction to ATX.