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

NCT02795637 | Completed Phase 1

• 1 other identifier: SEP360-103
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

Study of the what the body does to the drug in subjects with mild, moderate, and sever liver dysfunction (not working properly)

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Binge-Eating Disorder Disorder

Keywords

Attention deficit hyperactivity disorder (ADHD),; Binge-Eating Disorder (BED)

Outcome Measures

Primary Outcomes (2)

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

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

  Day 1 -28

• Plasma PK parameters: time of occurrence of Cmax

  Plasma PK parameters: time of occurrence of Cmax

  Day 1 -28

Secondary Outcomes (13)

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

  Day 1 -28

• Urine PK parameters: renal clearance (CLR)

  Day 1 -28

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

  Day 1 -28

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

  0-24 hours

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

  Day 1 -28

Study Arms (1)

dasotraline

EXPERIMENTAL

dasotraline 8mg capsule/day

Drug: dasotraline

Interventions

dasotraline DRUG

dasotraline 8mg capsule/day

Also known as: SEP225289

dasotraline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with non-impaired hepatic function must meet all of the following criteria:
• Male or nonpregnant, nonlactating female between 18 and 70 years of age.
• Subject must have a normal neurologic exam including tests for impending hepatic encephalopathy.
• Subject's weight is at least 50 kg.
• Subject's body mass index (BMI) is at least 18 kg/m2 but no more than 37 kg/m2
• Subject must be in general good health be demographically comparable to a least 1 subject with hepatic impairment who completed the study.
• Subject has a negative urine drug screen (UDS).
• Subjects with hepatic impairment must meet all of the following criteria:
• Male or nonpregnant, nonlactating female between 18 and 70 years of age.
• Subject must have a normal neurologic exam including tests for impending hepatic encephalopathy. Note: Subjects with grade 0 or 1 hepatic encephalopathy will be considered for enrollment in the study.
• Subject's weight is at least 50 kg.
• Subject's BMI is at least 18 kg/m2 but no more than 37 kg/
• Subject has a negative UDS.
• Subject with stable, chronic medical conditions (eg, hypertension and hyperlipidemia) in addition to hepatic impairment that, in the opinion of the investigator, will not significantly alter the disposition of the study drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data may be permitted to enroll in the study after discussion and agreement between the investigator and medical monitor.
• Subject exhibits vital signs within the reference range for their age and level of hepatic impairment; subjects with vital signs outside the reference ranges may be eligible for the study if the investigator and medical monitor agree that the results are not clinically significant based on the age and hepatic impairment status of the subject, and will not impact study conduct.

You may not qualify if:

• Any subject with non-impaired hepatic function meeting any of the following criteria will be excluded:
• Subject who does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
• Subject has any clinically significant unstable medical abnormality, chronic disease, or history of clinically significant abnormality of the cardiovascular, respiratory, hepatic or renal systems.
• Subject has any clinically significant abnormal medical history, physical examination, ECG, or laboratory results.
• Subject has estimated creatinine clearance ≤ 60 mL/min according to the Cockcroft Gault equation.
• Subject has had an acute illness within 30 days prior to administration of study drug.
• Subject who, within 14 days prior to administration of study drug, has had a febrile illness.
• Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism or excretion including clinically significant abnormality of the hepatic or renal system, a history of malabsorption, or previous gastrointestinal surgery that could affect drug absorption or metabolism.
• Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder (including intellectual disability and substance-related disorders).
• Subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C SSRS. Subjects who have significant findings for suicidal ideation upon completion of the C SSRS must be referred to the investigator for follow-up evaluation.
• Female subject who is pregnant, lactating, or within 6 months postpartum.
• Subject tests positive at screening for the hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus (HIV 1 or HIV 2) antibody.
• Subject has a positive urine alcohol test.
• Subject has history of substance-related disorder or alcohol related disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria within 1 year prior to screening.
• Subject has an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over age 65 and females). 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (5)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

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

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Binge-Eating Disorder

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine; SEP 225289

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Feeding and Eating Disorders

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

US (5)