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A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951053
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the study medication) of JNJ-40411813.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-40411813 Drug: Placebo Drug: Citalopram Phase 1

Detailed Description:
This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (effect of the study medication will be compared with the effect of placebo [inactive substance]), comparator-controlled (effect of the study medication will be compared with the effect of FDA approved and marketed active substance [citalopram]), and 3-way crossover (method used to switch participants from one treatment arm to another treatment arm) study. This study will be double-blinded for treatment with placebo and JNJ-40411813; however, it will be open label (all people know the identity of the intervention) for treatment with citalopram. This study will consist of screening phase (within 28 days prior to the start of study medication), treatment phase, and follow-up phase (approximately 14 days after the last administration of study medication). Participants will be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period 1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled in this study (3 participants in each sequence). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be evaluated throughout the study duration. The total duration of study participation for a participant will be approximately 10 Weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Blinded, Placebo- and Comparator-Controlled Three-way Crossover Study to Investigate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Male Subjects
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram

Arm Intervention/treatment
Experimental: Sequence 1
Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Experimental: Sequence 2
Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Experimental: Sequence 3
Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Experimental: Sequence 4
Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Experimental: Sequence 5
Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Experimental: Sequence 6
Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
Drug: JNJ-40411813
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Drug: Placebo
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Drug: Citalopram
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.




Primary Outcome Measures :
  1. Rapid Eye Movement (REM) sleep latency [ Time Frame: Day 3 and Day 4 ]
    REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).

  2. Total duration of Rapid Eye Movement (REM) sleep [ Time Frame: Day 3 and Day 4 ]
    Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2.

  3. Total time spent in deep sleep [ Time Frame: Day 3 and Day 4 ]
    Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of stages score as 3 or stage 4 divided by 2.

  4. Number of participants with adverse events as a measure of safety [ Time Frame: Up to Week 10 ]

Secondary Outcome Measures :
  1. Peak plasma concentration of JNJ-40411813 [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  2. Time to reach the peak plasma concentration of JNJ-40411813 [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  3. Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  4. Area under the plasma concentration of JNJ-40411813-time curve from 0 to infinity post dosing [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  5. Elimination rate constant of JNJ-40411813 [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  6. Terminal half-life of JNJ-40411813 [ Time Frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose) ]
    This sample will be used for pharmacokinetics analysis.

  7. Time in bed [ Time Frame: Day 3 and Day 4 ]
    Time in bed is defined as time from 'lights out' to 'lights on'.

  8. Latency to persistent sleep [ Time Frame: Day 3 and Day 4 ]
    Latency to persistent sleep is defined as time from 'lights out' to 'sleep onset'. Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  9. Sleep onset latency [ Time Frame: Day 3 and Day 4 ]
    Sleep onset latency is defined as time from 'lights out' to the beginning of 20 seconds epochs which have to be scored as sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  10. Total sleep time [ Time Frame: Day 3 and Day 4 ]
    Total sleep time is the duration of Rapid Eye Movement (REM) sleep plus non-REM sleep (sleep stages: S1: light sleep, S2: light sleep, and S3: deep sleep).

  11. Sleep efficiency [ Time Frame: Day 3 and Day 4 ]
    Sleep efficiency is calculated as total sleep time divided by time in bed.

  12. Number of awakenings [ Time Frame: Day 3 and Day 4 ]
    Number of awakenings is defined as number of stage shift from any sleep stage to wake. Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  13. Time spent awake after sleep onset [ Time Frame: Day 3 and Day 4 ]
    Time spent awake after sleep onset is defined as number of epochs scored as 'wake' (from the beginning of latency to persistent sleep until 'lights on'). Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  14. Duration of REM Sleep [ Time Frame: Day 3 and Day 4 ]
    Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).

  15. Duration of Stage 1 Sleep [ Time Frame: Day 3 and Day 4 ]
    Duration of Stage 1 Sleep is the number of minutes spent in stage 1 from 'lights out' to 'lights on'. Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  16. Duration of Stage 2 Sleep [ Time Frame: Day 3 and Day 4 ]
    Duration of Stage 2 Sleep is the number of minutes spent in stage 2 from 'lights out' to 'lights on'. Polysomnographic recordings will be used to determine the time spent in different sleep stages.

  17. Number of REM blocs [ Time Frame: Day 3 and Day 4 ]
    Number of REM blocs is defined as number of rapid eye movement episodes with a duration of at least 5 minutes. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])

Exclusion Criteria:

  • Significant history of or current significant medical illness including (but not limited to) liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers clinically significant
  • History of a relevant sleep disorder and / or receiving treatment for sleep disorders
  • Regular or periodic use of benzodiazepines
  • Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
  • Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication
  • Use of any prescription medication or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of start of study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951053


Locations
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Germany
Berlin, Germany
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01951053    
Other Study ID Numbers: CR100064
40411813EDI1003 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development )
2009-016637-95 ( EudraCT Number )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
JNJ-40411813
Positive allosteric modulator
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents