HealthyPhase 1NCT02578472
Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants
A Phase 1 study testing JNJ-42847922 and Zolpidem in people with Healthy, run by Janssen-Cilag International NV at 1 site in Netherlands.
Trial summary
The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42847922 and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Feb 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive)
- Men who are sexually active with a woman of childbearing potential must agree to use a condom, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, for men who have not had a vasectomy, their female partners should also use an appropriate method of birth control for at least the same duration
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose on Day 1 of each period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
- Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
- Women of childbearing potential must practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies (that is, one that results in a less than 1 percent per year failure rate when used consistently and correctly)
Who cannot join
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Subject has a history of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates [including methadone], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission on Day 1 of each study period
- Current suicidal or homicidal ideation/intent/behavior
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or Human immunodeficiency virus (HIV) antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Controlled, 3-way Crossover, Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Subjects
The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose.
Read the detailed description
This is a single center, double-blind (neither Investigator nor participant knows which treatment the participant receives), randomized (study drug assigned by chance), 3-way cross-over (the same medications provided to all participants but in different sequence), pilot study in healthy male and female participants. Participants will be randomly assigned to 1 of 6 treatment and planning sequences. The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. The double-blind crossover treatment phase will consist of 3 treatment periods separated by a washout period of at least 3 days between dosing. Participants will receive either Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922), Treatment B (10 mg zolpidem and 1 placebo capsule) or Treatment C (2 placebo capsules) in each treatment period. Driving performance will be assessed primarily by the mean difference of standard deviation of lateral position (SDLP) from an on road driving test. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- JNJ-42847922, Zolpidem, Placebo
- Keywords
- Healthy, JNJ-42847922, zolpidem, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42847922Drug
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
ZolpidemDrug
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
PlaceboDrug
Matching Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Sequence ABC) | Experimental | Participants will receive Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922) in Period 1, Treatment B (10 mg zolpidem and 1 placebo capsule) in Period 2 and Treatment C (2 placebo capsules) in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
| Group 2 (Sequence BCA) | Experimental | Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
| Group 3 (Sequence CAB) | Experimental | Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
| Group 4 (Sequence ABC) | Experimental | Participants will receive Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
| Group 5 (Sequence BCA) | Experimental | Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
| Group 6 (Sequence CAB) | Experimental | Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. Receives: Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
The SDLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: up to 8 hours post-dose
Secondary outcomes (19)
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
The MLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: 2 to 8 hours post-dose
Distance-keeping Assessed From an On-road Driving Test
Distance-keeping will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: 2 to 8 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
The MS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: 2 to 8 hours post-dose
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
The SDS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: 2 to 8 hours post-dose
Number of Head movements Assessed From an On-road Driving Test
Number of head movements will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
Measured: 2 to 8 hours post-dose
Reaction-time Assessed From an On-road Driving Test
Reaction-time will be assessed by 10 minutes of special and unexpected traffic events.
Measured: 2 to 8 hours post-dose
Inhibition-time Assessed From an On-road Driving Test
Inhibition-time will be assessed by 10 minutes of special and unexpected traffic events.
Measured: 2 to 8 hours post-dose
Alertness-time Assessed From an On-road Driving Test
Alertness-time will be assessed by 10 minutes of special and unexpected traffic events.
Measured: 2 to 8 hours post-dose
Drive safety Score (DSS)
The DSS is a composite score of driving simulator behavior ranging from 0-10, related to actual driving performance.
Measured: 2 to 8 hours post-dose
Subjective assessment of driving performance using visual analog scale
Participants indicated the perceived quality of their driving performance on a visual analog scale, which ranged from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well') around a midpoint of 'I drove normally'.
Measured: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Detection (DET) Test
Simple reaction time task measuring processing speed; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
Measured: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Identification (IDN) Test
Choice reaction time paradigm measuring attention; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
Measured: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: One Back (OBK) Test
Working memory measure; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
Measured: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: One card learning
A visual recall test scored using arcsine transformation of the proportion of correct responses.
Measured: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
TMT-B is a paper-and-pencil measure of divided attention and executive function (tracking, sequencing). The participant is instructed do draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters. The participant is instructed to work as quickly as possible while still maintaining accuracy. The test requires approximately 2 minutes to complete, alternate forms are available. Scores include time to completion and errors.
Measured: 2 to 8 hours post-dose
Postural Stability Test
Postural stability will be measured by body sway meter which allows measurement of body movements in a single plane. Body sway is measured with a pot string meter (celesco) based on the Wright ataxiameter (Wright, 1971). With a string attached to the waist, all body movements over a period of time are integrated and expressed as millimeter sway. The total period of body sway measurement will be two minutes.
Measured: 2 to 8 hours post-dose
Karolinska Sleepiness Scale (KSS) Score
The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).
Measured: 2 to 8 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: up to Follow-up (7-10 days after last dose of study drug)
Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922
Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922 will be reported.
Measured: Pre-dose and Day 1 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578472
- Sponsor's protocol ID
- CR108056
- Other IDs
- 42847922EDI1011, 2015-004203-24, 2015
- Status last verified
- Mar 2016
- First submitted
- 15 Oct 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled, 3-way Crossover, Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02578472
- Acronym / sponsor ID
- CR108056
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42847922, zolpidem, Placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Oct 2015 (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 effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose.
Detailed description
This is a single center, double-blind (neither Investigator nor participant knows which treatment the participant receives), randomized (study drug assigned by chance), 3-way cross-over (the same medications provided to all participants but in different sequence), pilot study in healthy male and female participants. Participants will be randomly assigned to 1 of 6 treatment and planning sequences. The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. The double-blind crossover treatment phase will consist of 3 treatment periods separated by a washout period of at least 3 days between dosing. Participants will receive either Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922), Treatment B (10 mg zolpidem and 1 placebo capsule) or Treatment C (2 placebo capsules) in each treatment period. Driving performance will be assessed primarily by the mean difference of standard deviation of lateral position (SDLP) from an on road driving test. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Sequence ABC) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922) in Period 1, Treatment B (10 mg zolpidem and 1 placebo capsule) in Period 2 and Treatment C (2 placebo capsules) in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. |
| Group 2 (Sequence BCA) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. |
| Group 3 (Sequence CAB) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing. |
| Group 4 (Sequence ABC) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. |
| Group 5 (Sequence BCA) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. |
| Group 6 (Sequence CAB) | Experimental | Drug: JNJ-42847922, Drug: Zolpidem, Drug: PlaceboParticipants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive)
- Men who are sexually active with a woman of childbearing potential must agree to use a condom, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, for men who have not had a vasectomy, their female partners should also use an appropriate method of birth control for at least the same duration
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose on Day 1 of each period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
- Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
Key exclusion criteria (5 listed)
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Subject has a history of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates [including methadone], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission on Day 1 of each study period
- Current suicidal or homicidal ideation/intent/behavior
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or Human immunodeficiency virus (HIV) antibodies
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-42847922JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods. | Drug | Group 1 (Sequence ABC), Group 2 (Sequence BCA), Group 3 (Sequence CAB), Group 4 (Sequence ABC), Group 5 (Sequence BCA), Group 6 (Sequence CAB) |
| ZolpidemZolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods. | Drug | Group 1 (Sequence ABC), Group 2 (Sequence BCA), Group 3 (Sequence CAB), Group 4 (Sequence ABC), Group 5 (Sequence BCA), Group 6 (Sequence CAB) |
| PlaceboMatching Placebo will be administered orally. | Drug | Group 1 (Sequence ABC), Group 2 (Sequence BCA), Group 3 (Sequence CAB), Group 4 (Sequence ABC), Group 5 (Sequence BCA), Group 6 (Sequence CAB) |
Primary outcome
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Time frame: up to 8 hours post-dose
The SDLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
19 secondary outcomes
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Distance-keeping Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Number of Head movements Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Reaction-time Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Inhibition-time Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Alertness-time Assessed From an On-road Driving Test
Time frame: 2 to 8 hours post-dose
Drive safety Score (DSS)
Time frame: 2 to 8 hours post-dose
Subjective assessment of driving performance using visual analog scale
Time frame: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Detection (DET) Test
Time frame: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Identification (IDN) Test
Time frame: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: One Back (OBK) Test
Time frame: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: One card learning
Time frame: 2 to 8 hours post-dose
Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
Time frame: 2 to 8 hours post-dose
Postural Stability Test
Time frame: 2 to 8 hours post-dose
Karolinska Sleepiness Scale (KSS) Score
Time frame: 2 to 8 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to Follow-up (7-10 days after last dose of study drug)
Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922
Time frame: Pre-dose and Day 1 post-dose
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 24 Mar 2016.
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
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-42847922 and Zolpidem in people with Healthy, run by Janssen-Cilag International NV at 1 site in Netherlands.
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 6 inclusion and 5 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 24 Mar 2016. 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 Netherlands. 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?
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test (time frame: up to 8 hours post-dose). 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 24 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.