A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | November 2015 |
End Date: | November 2016 |
Email: | JNJ.CT@sylogent.com |
An Open-Label, Single-Dose, Parallel-Group Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of
intranasally administered esketamine in both participants with varying stages of hepatic
impairment and healthy participants.
intranasally administered esketamine in both participants with varying stages of hepatic
impairment and healthy participants.
This is a parallel group, single-center, single-dose, open-label (all people know the
identity of the intervention), study to assess the pharmacokinetics and safety of a single
28 milligram (mg) dose of esketamine in both participants with varying stages of hepatic
impairment and healthy participants. The participants will be assigned to 1 of 3 groups (8
participants per group) based on hepatic impairment which will be classified during
Screening. Cohort 1 (participants with moderate hepatic impairment), Cohort 2 (participants
with mild hepatic impairment), and Cohort 3 (participants with normal hepatic function and
no evidence of liver damage). Participants will self-administer a single dose of intranasal
Esketamine 28 mg. The total duration of the study from Screening through Follow-up, is
approximately 34 to 38 days. Blood and urine samples for assessment of Esketamine
pharmacokinetics will be collected for up to 60 hours after study drug administration.
Participants' safety will be monitored throughout the study.
identity of the intervention), study to assess the pharmacokinetics and safety of a single
28 milligram (mg) dose of esketamine in both participants with varying stages of hepatic
impairment and healthy participants. The participants will be assigned to 1 of 3 groups (8
participants per group) based on hepatic impairment which will be classified during
Screening. Cohort 1 (participants with moderate hepatic impairment), Cohort 2 (participants
with mild hepatic impairment), and Cohort 3 (participants with normal hepatic function and
no evidence of liver damage). Participants will self-administer a single dose of intranasal
Esketamine 28 mg. The total duration of the study from Screening through Follow-up, is
approximately 34 to 38 days. Blood and urine samples for assessment of Esketamine
pharmacokinetics will be collected for up to 60 hours after study drug administration.
Participants' safety will be monitored throughout the study.
Inclusion Criteria:
Cohorts 1, 2 and 3 (All participants):
- Body mass index (BMI) between 18 and 34 kilogram (kg)/meter square ([m]^2)
(inclusive), and body weight not less than 50 kilogram (kg)
- Creatinine clearance of greater than or equal to (> =) 60 milliliter per minute
(mL/min) based on the Cockcroft-Gault equation
- Signed an informed consent document indicating they understand the purpose of and
procedures required for the study and are willing to participate in the study
Cohorts 1 and 2 (Participants with Hepatic impairment):
- A total Child-Pugh score of 5 or 6 for participants with mild impairment and between
7 and 9 (inclusive) for participants with moderate impairment
- Participants must have stable hepatic function and consistent classification (mild or
moderate hepatic impairment) between Screening and Day -1
Exclusion Criteria:
Cohorts 1, 2 and 3 (All participants):
- Participants of Asian origin
- Diagnosed with a current or previous psychotic or major depressive disorder (MDD)
with psychosis, bipolar or related disorder, intellectual disability, borderline
personality disorder, or antisocial personality disorder
Cohorts 1 and 2 (Participants with Hepatic impairment):
- History of hepatopulmonary syndrome, hydrothorax or hepatorenal syndrome
- Positive test for alcohol or drugs of abuse per local standard practices
Cohorts 3 (Healthy participants):
- Clinically significant medical illness
- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at Screening or at admission to the study center (Day -1) as deemed
appropriate by the investigator
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B
surface antigen (HBsAg), or hepatitis C antibodies at Screening
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