A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

NCT ID: NCT02611505

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-02-27

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatic Impairment; Normal Hepatic Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants with moderate hepatic impairment will receive esketamine solution (containing 14 milligram \[mg\] of esketamine base per 100 microliter \[mcl\]) by intranasal route into each nostril using nasal spray pump at 0 hour (h) on Day 1.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.

Cohort 2

Participants with mild hepatic impairment will receive esketamine solution (containing 14 mg of esketamine base per 100 mcl) by intranasal route into each nostril using nasal spray pump at 0h on Day 1.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.

Cohort 3

Participants with normal hepatic function and no evidence of liver damage will receive esketamine solution (containing 14 mg of esketamine base per 100 mcl) by intranasal route into each nostril using nasal spray pump at 0h on Day 1.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.

Interventions

Esketamine

Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.

Intervention Type: DRUG

Other Intervention Names

JNJ-54135419

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

ESKETINTRD1011

Identifier Type: OTHER

Identifier Source: secondary_id

CR108098

Identifier Type: -

Identifier Source: org_study_id