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Completed

NCT Number: NCT02345148

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

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).

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esketamine

Drug

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

Other names: Esketamine hydrochloride, JNJ-54135419

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: up to 24 hours after study drug administration

    The Cmax is the maximum plasma concentration.

  2. Time to reach maximum concentration (tmax)

    Time frame: up to 24 hours after study drug administration

    The Tmax is time to reach the maximum plasma concentration.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours (AUC [0-12])

    Time frame: up to 24 hours after study drug administration

    The AUC (0-12) is the area under the plasma concentration-time curve from time 0 to 12 hours post-dose.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last])

    Time frame: up to 24 hours after study drug administration

    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.

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

    Time frame: up to 24 hours after study drug administration

    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.

  6. Elimination half-life period (t1/2) associated with the terminal slope (Lambda z)

    Time frame: up to 24 hours after study drug administration

    Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  7. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 42 days

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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