Attention Deficit Hyperactivity Disorder (ADHD)

Binge-Eating Disorder Disorder

dasotraline

Clinical Pharmacology of Miami, Inc.

Orlando Clinical Research Center

Atlanta Center for Medical Research

DaVita Clinical Research

American Research Cororation (ARC), Texas Liver Instituete (TLI)

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

Pharmacokinetics of Orally Administered Dasotraline in Subjects With Mild, Moderate, and Severe Hepatic Dysfunction

Plasma PK parameters: Area under the plasma/serum concentration-time curve from time zero to infinity (AUC0 inf)

Plasma PK parameters: time of occurrence of Cmax

Urine PK parameters: amount excreted in urine from time zero to time t (AEx0 t)

Urine PK parameters: renal clearance (CLR)

Urine PK parameters: percent of dose excreted in urine (%fe)

Unbound fraction of dasotraline in plasma at 10, 12, and 24 hours postdose .

Incidence of adverse events (AEs), SAEs, and AEs resulting in study discontinuation.

Absolute values and changes from baseline in clinical laboratory tests (hematology, serum chemistry, urinalysis, prothrombin time), vital signs (respiratory rate, body temperature, supine blood pressure, and supine pulse rate), and 12 lead ECGs.

Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS).

Plasma PK parameters: AUC0-last, area under the blood concentration time curve from time zero to 24 hours postdose (AUC0-24)

Plasma PK parameters: time of occurrence of Cmax (tmax)

Plasma PK parameters: apparent clearance (CL/F)

Plasma PK parameters: apparent volume of distribution (Vz/F)

esophageal and gastric varices/potassio

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

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