Ketamine Challenge Study With JNJ-40411813

NCT01101659 | Completed Phase 1

• 1 other identifier: CR017161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Perceptual Disorders; Confusion; Schizophrenia

Keywords

Activity of JNJ-40411813; Challenge study

Outcome Measures

Primary Outcomes (1)

• 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

  15 minutes after start of bolus injection of ketamine

Secondary Outcomes (3)

• 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

  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

  3, 12 and 24 hours after dosing of JNJ 40411813

• Investigate the safety, tolerability, and pharmacokinetics of JNJ 40411813 in healthy volunteers

  During each Period on Days 1, 2 and 3 (if applicable) and at follow up

Study Arms (4)

001

EXPERIMENTAL

JNJ-40411813 500 mg as 20 mL of oral suspension single dose

Drug: JNJ-40411813

002

PLACEBO COMPARATOR

Placebo 20 mL of oral suspension single dose

Drug: Placebo

003

OTHER

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

Drug: ketamine

004

OTHER

normal saline infusion 0.5 mL /min over 90 minutes

Drug: normal saline

Interventions

JNJ-40411813 DRUG

500 mg as 20 mL of oral suspension

001

normal saline DRUG

single dose

004

ketamine DRUG

20 mL of oral suspension

003

Placebo DRUG

single dose

002

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

Related Publications (2)

• Salih H, Anghelescu I, Kezic I, Sinha V, Hoeben E, Van Nueten L, De Smedt H, De Boer P. Pharmacokinetic and pharmacodynamic characterisation of JNJ-40411813, a positive allosteric modulator of mGluR2, in two randomised, double-blind phase-I studies. J Psychopharmacol. 2015 Apr;29(4):414-25. doi: 10.1177/0269881115573403. Epub 2015 Mar 3.

  PMID: 25735992 DERIVED

• Kleinloog D, Uit den Boogaard A, Dahan A, Mooren R, Klaassen E, Stevens J, Freijer J, van Gerven J. Optimizing the glutamatergic challenge model for psychosis, using S+ -ketamine to induce psychomimetic symptoms in healthy volunteers. J Psychopharmacol. 2015 Apr;29(4):401-13. doi: 10.1177/0269881115570082. Epub 2015 Feb 17.

  PMID: 25693889 DERIVED

MeSH Terms

Conditions

Perceptual Disorders; Confusion; Schizophrenia

Interventions

1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone; Saline Solution; Ketamine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

DE (1)