HealthyPhase 1NCT01951053
A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients
A Phase 1 study testing JNJ-40411813 and Citalopram in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-40411813 and Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- JNJ-40411813, Placebo, Citalopram
- Keywords
- Healthy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, JNJ-40411813, Positive allosteric modulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-40411813Drug
Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.
PlaceboDrug
Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.
CitalopramDrug
Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
| Sequence 2 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
| Sequence 3 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
| Sequence 4 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
| Sequence 5 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
| Sequence 6 | Experimental | 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. Receives: Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Eye Movement (REM) sleep latency
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).
Measured: Day 3 and Day 4
Total duration of Rapid Eye Movement (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). It will be calculated as number of epochs scored as REM sleep divided by 2.
Measured: Day 3 and Day 4
Total time spent in deep 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). It will be calculated as number of stages score as 3 or stage 4 divided by 2.
Measured: Day 3 and Day 4
Number of participants with adverse events as a measure of safety
Measured: Up to Week 10
Secondary outcomes (17)
Peak plasma concentration of JNJ-40411813
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Time to reach the peak plasma concentration of JNJ-40411813
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Area under the plasma concentration of JNJ-40411813-time curve from 0 to infinity post dosing
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Elimination rate constant of JNJ-40411813
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Terminal half-life of JNJ-40411813
This sample will be used for pharmacokinetics analysis.
Measured: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Time in bed
Time in bed is defined as time from 'lights out' to 'lights on'.
Measured: Day 3 and Day 4
Latency to persistent sleep
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.
Measured: Day 3 and Day 4
Sleep onset latency
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.
Measured: Day 3 and Day 4
Total sleep time
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).
Measured: Day 3 and Day 4
Sleep efficiency
Sleep efficiency is calculated as total sleep time divided by time in bed.
Measured: Day 3 and Day 4
Number of awakenings
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.
Measured: Day 3 and Day 4
Time spent awake after sleep onset
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.
Measured: Day 3 and Day 4
Duration 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).
Measured: Day 3 and Day 4
Duration of Stage 1 Sleep
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.
Measured: Day 3 and Day 4
Duration of Stage 2 Sleep
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.
Measured: Day 3 and Day 4
Number of REM blocs
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).
Measured: Day 3 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951053
- Sponsor's protocol ID
- CR100064
- Other IDs
- 40411813EDI1003, 2009-016637-95, 2009
- Status last verified
- Sep 2013
- First submitted
- 27 Aug 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01951053
- Acronym / sponsor ID
- CR100064
- Conditions
- Healthy
- Keywords
- Healthy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, JNJ-40411813, Positive allosteric modulator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
| Sequence 2 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
| Sequence 3 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
| Sequence 4 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
| Sequence 5 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
| Sequence 6 | Experimental | Drug: JNJ-40411813, Drug: Placebo, Drug: CitalopramParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-40411813Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| PlaceboParticipants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| CitalopramParticipants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
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).
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.
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.
Number of participants with adverse events as a measure of safety
Time frame: Up to Week 10
17 secondary outcomes
Peak plasma concentration of JNJ-40411813
Time frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Time to reach the peak plasma concentration of JNJ-40411813
Time frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
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)
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)
Elimination rate constant of JNJ-40411813
Time frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Terminal half-life of JNJ-40411813
Time frame: Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)
Time in bed
Time frame: Day 3 and Day 4
Latency to persistent sleep
Time frame: Day 3 and Day 4
Sleep onset latency
Time frame: Day 3 and Day 4
Total sleep time
Time frame: Day 3 and Day 4
Sleep efficiency
Time frame: Day 3 and Day 4
Number of awakenings
Time frame: Day 3 and Day 4
Time spent awake after sleep onset
Time frame: Day 3 and Day 4
Duration of REM Sleep
Time frame: Day 3 and Day 4
Duration of Stage 1 Sleep
Time frame: Day 3 and Day 4
Duration of Stage 2 Sleep
Time frame: Day 3 and Day 4
Number of REM blocs
Time frame: Day 3 and Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-40411813 and Citalopram in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Eye Movement (REM) sleep latency (time frame: Day 3 and Day 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.