Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

Healthy Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Elderly (>= 75 Years of Age) and Healthy Younger Adult Subjects (18 to 55 Years of Age, Inclusive)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345148
• Other study ID #: CR106172
• Secondary ID: ESKETINTRD101220
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2015
• Last updated: March 2, 2017
• Start date: December 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to [>=] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).

Description:

This is a single-center, 2-cohort, single-dose, open-label study. The duration of study will be approximately 42 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1) and open-label Treatment (Day 1) and Follow-up (up to Day 13). Esketamine will be administered by intranasal route (delivery of medications through the nasal mucosa) on Day 1. Participants' safety will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For Cohort 1, be a man or woman, >= 75 years of age who are either healthy or who present with stable, well-controlled, chronic conditions which frequently occur in the elderly, such as: hyperlipidemia; controlled hypertension; impaired fasting glucose, impaired glucose tolerance or type 2 diabetes mellitus controlled with diet, and/or metformin monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels less than 8 percent; degenerative joint disorders and osteoporosis; kidney function decline appropriate for age. Inclusion of participants with other chronic, well-controlled and stable conditions to Cohort 1 should be reviewed and agreed between the Investigator and the Sponsor

• For Cohort 2, be a man or woman, 18 to 55 years of age, inclusive

• For women of childbearing potential in Cohort 2, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1

• If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug

• Body mass index (BMI) (weight [kg]/height^2 [m]^2) between 18 and 32 kg/m^2 (inclusive), and body weight not less than 50 kg

Exclusion Criteria:

• Diagnosed with a current or previous psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder

• Clinically significant medical illness

• Severe renal impairment

• 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

• History of drug or alcohol abuse disorder within the past 1 year, or a reason to believe a participant has such a history

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Esketamine
Esketamine 84 mg will be self-administered by participants as intranasal spray at 0, 5 and 10 minutes on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	The Cmax is the maximum plasma concentration.	up to 24 hours after study drug administration
Primary	Time to reach maximum concentration (tmax)	The Tmax is time to reach the maximum plasma concentration.	up to 24 hours after study drug administration
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours (AUC [0-12])	The AUC (0-12) is the area under the plasma concentration-time curve from time 0 to 12 hours post-dose.	up to 24 hours after study drug administration
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last])	The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.	up to 24 hours after study drug administration
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.	up to 24 hours after study drug administration
Primary	Elimination half-life period (t1/2) associated with the terminal slope (Lambda z)	Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).	up to 24 hours after study drug administration
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	42 days