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Ketamine Challenge Study With JNJ-40411813

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ClinicalTrials.gov Identifier: NCT01101659
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE April 8, 2010
First Posted Date  ICMJE April 12, 2010
Last Update Posted Date April 8, 2014
Study Start Date  ICMJE February 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
To investigate the effect of JNJ- 40411813 on ketamine-induced positive psychotic symptoms based on 4 items of the brief psychiatric rating scale (BPRS) in healthy male volunteers [ Time Frame: 15 minutes after start of bolus injection of ketamine ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
To investigate the effect of JNJ- 40411813 on ketamine-induced positive psychotic symptoms based on 4 items of the brief psyciatric rating scale (BPRS) in healthy male volunteers [ Time Frame: 15 minutes after start of bolus injection of ketamine ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
  • Investigate the effects of JNJ 40411813 on ketamine-induced negative symptoms,based on 3 items of the BPRS, dissociative effects (based on the 5-dimensions altered state of consciousness (5D-ASC), and cognitive performance [ Time Frame: 15 min, 30 to 60 min after start of bolus injection of ketamine and at the end of ketamine infusion ]
  • Investigate the duration of action and the concentration-effect relationship of JNJ 40411813 [ Time Frame: 3, 12 and 24 hours after dosing of JNJ 40411813 ]
  • Investigate the safety, tolerability, and pharmacokinetics of JNJ 40411813 in healthy volunteers [ Time Frame: During each Period on Days 1, 2 and 3 (if applicable) and at follow up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
  • Investigate the effects of JNJ 40411813 on ketamine-induced negative symptoms,based on 3 items of the BPRS, dissociative effects (based on the 5-dimensions altered state of conciousness (5D-ASC), and cognitive performance [ Time Frame: 15 min, 30 to 60 min after start of bolus injection of ketamine and at the end of ketamine infusion ]
  • Investigate the duration of action and the concentration-effect relationship of JNJ 40411813 [ Time Frame: 3, 12 and 24 hours after dosing of JNJ 40411813 ]
  • Investigate the safety, tolerability, and pharmacokinetics of JNJ 40411813 in healthy volunteers [ Time Frame: During each Period on Days 1, 2 and 3 (if applicable) and at follow up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Challenge Study With JNJ-40411813
Official Title  ICMJE A Double-Blind, 2-Way Crossover Study to Investigate the Effects of JNJ-40411813 on Ketamine-Induced Alterations in Neuropsychiatric Performance
Brief Summary The objective of this study is to investigate whether JNJ-40411813 versus placebo reduces psychosis-like symptoms, induced by infusion of a low dose of ketamine. Effects of JNJ-40411813 on ketamine-induced symptoms will be evaluated about 3 hours after a single oral dose when the concentration of JNJ-40411813 in the blood is at its maximum and up to 24 hours after dose administration to assess the duration of a potential JNJ-40411813 effect.
Detailed Description This will be a double-blind (neither physician nor the volunteer knowns whether placebo or active drug is administered), placebo-controlled, randomized (study drug is assigned by chance), 2-way crossover (the same procedure is repeated twice so that the volunteer receives placebo as well as active drug) study in cohorts of a maximum of 16 healthy male volunteers each, to investigate the effect of JNJ 40411813 or placebo on ketamine-induced psychosis-like symptoms. In the first cohort (Cohort 1), JNJ 40411813 effects at a dose level of 500 mg will be evaluated at the time of maximal plasma concentrations. If JNJ 40411813 significantly reduces psychotic symptoms relative to placebo, a second cohort (Cohort 2) will be initiated to investigate the effects of JNJ 40411813 at 24 hours following dose administration. If Cohort 1 shows no relevant effects of JNJ 40411813 the study will be stopped. If there are no relevant effects of JNJ 40411813 on the psychotic symptoms at 24 hours after dosing, a third cohort (Cohort 3) will be initiated to investigate the effects at 12 hours after dosing. If there are relevant effects of JNJ 40411813 at 24 hours after dosing, a fourth cohort (Cohort 4) following the same procedures as Cohort 1, will be initiated to investigate the effects at peak plasma concentration using a lower dose of JNJ 40411813. Volunteers will be randomly assigned in a crossover procedure to one of two sequences (JNJ 40411813/placebo or placebo/ JNJ 40411813) on Day -1 of the first study period of each cohort. At peak plasma level (Cohorts 1 and 4), 24 hours (Cohort 2) or 12 hours (Cohort 3) after dosing volunteers will receive ketamine as an infusion (i.e. directly into the vein) over 60 minutes. The ketamine administration will be preceded by a saline infusion over 90 minutes. Tests on the psychological function of the volunteers will be performed during and after saline and ketamine infusion. Safety assessments include daily ECG and vital signs, clinical laboratory assessments at the start and end of each study period, pulse oximetry (measurement of the oxygen content of the blood ) during each ketamine infusion and continuous Adverse Event Reporting. The study will be double blind for oral JNJ-40411813 or placebo, but open label (everyone knows the identity) for the IV administration of saline and ketamine. JNJ-40411813: 500 mg single oral dose or lower or matching placebo. Ketamine: continuous intravenous infusion of 0.005 mg/kg/min over 60 minutes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Basic Science
Condition  ICMJE
  • Perceptual Disorders
  • Confusion
  • Schizophrenia
Intervention  ICMJE
  • Drug: JNJ-40411813
    500 mg as 20 mL of oral suspension
  • Drug: normal saline
    single dose
  • Drug: ketamine
    20 mL of oral suspension
  • Drug: Placebo
    single dose
Study Arms  ICMJE
  • Experimental: 001
    JNJ-40411813 500 mg as 20 mL of oral suspension single dose
    Intervention: Drug: JNJ-40411813
  • Placebo Comparator: 002
    Placebo 20 mL of oral suspension single dose
    Intervention: Drug: Placebo
  • 003
    ketamine Ketanest S. vials of 20 ml with 5 mg/ml diluted with saline to 0.02 mg Ketamine per mL and per kg bodyweight of the volunteer
    Intervention: Drug: ketamine
  • 004
    normal saline infusion 0.5 mL /min over 90 minutes
    Intervention: Drug: normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
48
Actual Study Completion Date  ICMJE July 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) between 18 and 30 kg/m2
  • Nonsmokers
  • Healthy on the basis of a psychiatric examination according to the MINI screen
  • Healthy on the basis of clinical laboratory tests performed at screening
  • Healthy on the basis of physical examination, vital signs (including standing blood pressure and heart rate) or 12 lead ECG at Screening

Exclusion Criteria:

  • Having a contra-indication for the use of ketamine
  • Significant history of or current psychiatric or neurological illness
  • Positive urine screen for drugs of abuse at Screening or admission
  • Positive alcohol breath test at Screening or admission
  • History of alcohol or drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01101659
Other Study ID Numbers  ICMJE CR017161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP