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
23. März 2016 aktualisiert von: Janssen-Cilag International NV
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
36
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Leiden, Niederlande
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Group 1 (Sequence ABC)
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.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 2 (Sequence BCA)
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.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 3 (Sequence CAB)
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.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 4 (Sequence ABC)
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.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 5 (Sequence BCA)
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.
|
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 6 (Sequence CAB)
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.
|
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Zeitfenster: up to 8 hours post-dose
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The SDLP will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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up to 8 hours post-dose
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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The MLP will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Distance-keeping Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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Distance-keeping will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Mean Speed (MS) Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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The MS will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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The SDS will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Number of Head movements Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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Number of head movements will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Reaction-time Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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Reaction-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Inhibition-time Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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Inhibition-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Alertness-time Assessed From an On-road Driving Test
Zeitfenster: 2 to 8 hours post-dose
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Alertness-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Drive safety Score (DSS)
Zeitfenster: 2 to 8 hours post-dose
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The DSS is a composite score of driving simulator behavior ranging from 0-10, related to actual driving performance.
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2 to 8 hours post-dose
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Subjective assessment of driving performance using visual analog scale
Zeitfenster: 2 to 8 hours post-dose
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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'.
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Detection (DET) Test
Zeitfenster: 2 to 8 hours post-dose
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Simple reaction time task measuring processing speed; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Identification (IDN) Test
Zeitfenster: 2 to 8 hours post-dose
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Choice reaction time paradigm measuring attention; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: One Back (OBK) Test
Zeitfenster: 2 to 8 hours post-dose
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Working memory measure; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: One card learning
Zeitfenster: 2 to 8 hours post-dose
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A visual recall test scored using arcsine transformation of the proportion of correct responses.
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
Zeitfenster: 2 to 8 hours post-dose
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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.
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2 to 8 hours post-dose
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Postural Stability Test
Zeitfenster: 2 to 8 hours post-dose
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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.
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2 to 8 hours post-dose
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Karolinska Sleepiness Scale (KSS) Score
Zeitfenster: 2 to 8 hours post-dose
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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).
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2 to 8 hours post-dose
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: up to Follow-up (7-10 days after last dose of study drug)
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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.
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up to Follow-up (7-10 days after last dose of study drug)
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Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922
Zeitfenster: Pre-dose and Day 1 post-dose
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Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922 will be reported.
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Pre-dose and Day 1 post-dose
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2015
Primärer Abschluss (Tatsächlich)
1. Februar 2016
Studienabschluss (Tatsächlich)
1. Februar 2016
Studienanmeldedaten
Zuerst eingereicht
15. Oktober 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Oktober 2015
Zuerst gepostet (Schätzen)
19. Oktober 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
24. März 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. März 2016
Zuletzt verifiziert
1. März 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CR108056
- 42847922EDI1011 (Andere Kennung: Janssen-Cilag International NV)
- 2015-004203-24 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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