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Completed

NCT Number: NCT01951053

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

JNJ-40411813

Drug

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Drug

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

Citalopram

Drug

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2013
Registry last updated
Sep 26, 2013

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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