Clinical trials: Esketamine
Healthy
A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine using a device with and without a nasal guide in healthy…
- Trial name
- NCT02060929
- Testing
- Esketamine
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment, Normal Hepatic Function
A 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.
- Trial name
- NCT02611505
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian…
- Trial name
- NCT01980303
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Allergic Rhinitis
Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine
The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms affecting the nose) and co-administration of mometasone or oxymetazoline on the pharmacokinetics (explores what the body does to the…
- Trial name
- NCT02154334
- Testing
- Esketamine, Mometasone, Oxymetazoline
- Where
- Germany
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.
- Trial name
- NCT01780259
- Testing
- Esketamine, Triazolam
- Where
- Belgium
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
- Trial name
- NCT02674295
- Testing
- Esketamine 50 mg, Esketamine 20 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.
- Trial name
- NCT03808259
- Testing
- (S)-ketamine Oral Thin Film, (S)-ketamine IV Infusion
- Where
- Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the…
- Trial name
- NCT02846519
- Testing
- Esketamine, Rifampin
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study.
- Trial name
- NCT03407872
- Testing
- Esketamine DPI
- Where
- Poland
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Celon Pharma SA
Healthy
Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants
The primary purpose of this study is to evaluate the induction potential of repeated administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in healthy participants using orally administered…
- Trial name
- NCT02568176
- Testing
- Midazolam, Esketamine, Bupropion
- Where
- Belgium
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Drug Abuse
Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users
The primary objective of this study is to evaluate the abuse potential of intranasal esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in nondependent, recreational polydrug users of…
- Trial name
- NCT02682225
- Testing
- Intravenous racemic ketamine, Esketamine 112 mg, Esketamine 84 mg
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Renal Impairment, Healthy
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.
- Trial name
- NCT02606084
- Testing
- Esketamine
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants
The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine (intranasal administration) and supratherapeutic…
- Trial name
- NCT02737605
- Testing
- Intranasal Esketamine, Intravenous Esketamine, Moxifloxacin
- Where
- Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
- Trial name
- NCT04282746
- Testing
- JNJ-54135419
- Where
- Belgium
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects.
- Trial name
- NCT02857777
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants
The purpose of this study is to evaluate the effects of ticlopidine on the pharmacokinetics (PK) of intranasally administered esketamine.
- Trial name
- NCT03298906
- Testing
- Esketamine, Ticlopidine
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants
The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort…
- Trial name
- NCT02129088
- Testing
- Esketamine
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.
- Trial name
- NCT04300621
- Testing
- OTF 1, OTF 2, OTF 3
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of esketamine administered by the intranasal (administered through the nose) and oral routes and to evaluate the effects of clarithromycin on…
- Trial name
- NCT02343289
- Testing
- Esketamine, Clarithromycin
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants
The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in…
- Trial name
- DRiVESaFe (NCT02228239)
- Testing
- Esketamine, Mirtazapine
- Where
- Netherlands
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC