Clinical trial NCT01951053: A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
JNJ-40411813
Positive allosteric modulator
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility 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

Primary outcomes:
measure: Rapid Eye Movement (REM) sleep latency
timeFrame: Day 3 and Day 4
measure: Total duration of Rapid Eye Movement (REM) sleep
timeFrame: Day 3 and Day 4
measure: Total time spent in deep sleep
timeFrame: Day 3 and Day 4
measure: Number of participants with adverse events as a measure of safety
timeFrame: Up to Week 10
Secondary outcomes:
measure: Peak plasma concentration of JNJ-40411813
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Time to reach the peak plasma concentration of JNJ-40411813
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Area under the plasma concentration of JNJ-40411813-time curve from 0 to infinity post dosing
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Elimination rate constant of JNJ-40411813
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Terminal half-life of JNJ-40411813
timeFrame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
measure: Time in bed
timeFrame: Day 3 and Day 4
measure: Latency to persistent sleep
timeFrame: Day 3 and Day 4
measure: Sleep onset latency
timeFrame: Day 3 and Day 4
measure: Total sleep time
timeFrame: Day 3 and Day 4
measure: Sleep efficiency
timeFrame: Day 3 and Day 4
measure: Number of awakenings
timeFrame: Day 3 and Day 4
measure: Time spent awake after sleep onset
timeFrame: Day 3 and Day 4
measure: Duration of REM Sleep
timeFrame: Day 3 and Day 4
measure: Duration of Stage 1 Sleep
timeFrame: Day 3 and Day 4
measure: Duration of Stage 2 Sleep
timeFrame: Day 3 and Day 4
measure: Number of REM blocs
timeFrame: Day 3 and Day 4
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial
role: STUDY_DIRECTOR
References: