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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. března 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

36

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 55 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.
Experimentální: 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.
Lék: JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Lék: Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Lék: Placebo
Matching Placebo will be administered orally.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Časové okno: 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.
up to 8 hours post-dose

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
The MLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
2 to 8 hours post-dose
Distance-keeping Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
Distance-keeping will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
2 to 8 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
The MS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
2 to 8 hours post-dose
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
The SDS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
2 to 8 hours post-dose
Number of Head movements Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
Number of head movements will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.
2 to 8 hours post-dose
Reaction-time Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
Reaction-time will be assessed by 10 minutes of special and unexpected traffic events.
2 to 8 hours post-dose
Inhibition-time Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
Inhibition-time will be assessed by 10 minutes of special and unexpected traffic events.
2 to 8 hours post-dose
Alertness-time Assessed From an On-road Driving Test
Časové okno: 2 to 8 hours post-dose
Alertness-time will be assessed by 10 minutes of special and unexpected traffic events.
2 to 8 hours post-dose
Drive safety Score (DSS)
Časové okno: 2 to 8 hours post-dose
The DSS is a composite score of driving simulator behavior ranging from 0-10, related to actual driving performance.
2 to 8 hours post-dose
Subjective assessment of driving performance using visual analog scale
Časové okno: 2 to 8 hours post-dose
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'.
2 to 8 hours post-dose
Computerized Cognitive Test Battery: Detection (DET) Test
Časové okno: 2 to 8 hours post-dose
Simple reaction time task measuring processing speed; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
2 to 8 hours post-dose
Computerized Cognitive Test Battery: Identification (IDN) Test
Časové okno: 2 to 8 hours post-dose
Choice reaction time paradigm measuring attention; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
2 to 8 hours post-dose
Computerized Cognitive Test Battery: One Back (OBK) Test
Časové okno: 2 to 8 hours post-dose
Working memory measure; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
2 to 8 hours post-dose
Computerized Cognitive Test Battery: One card learning
Časové okno: 2 to 8 hours post-dose
A visual recall test scored using arcsine transformation of the proportion of correct responses.
2 to 8 hours post-dose
Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
Časové okno: 2 to 8 hours post-dose
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.
2 to 8 hours post-dose
Postural Stability Test
Časové okno: 2 to 8 hours post-dose
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.
2 to 8 hours post-dose
Karolinska Sleepiness Scale (KSS) Score
Časové okno: 2 to 8 hours post-dose
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).
2 to 8 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: up to Follow-up (7-10 days after last dose of study drug)
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.
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
Časové okno: Pre-dose and Day 1 post-dose
Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922 will be reported.
Pre-dose and Day 1 post-dose

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen-Cilag International NV

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2015

Primární dokončení (Aktuální)

1. února 2016

Dokončení studie (Aktuální)

1. února 2016

Termíny zápisu do studia

První předloženo

15. října 2015

První předloženo, které splnilo kritéria kontroly kvality

15. října 2015

První zveřejněno (Odhad)

19. října 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

24. března 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. března 2016

Naposledy ověřeno

1. března 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CR108056
  • 42847922EDI1011 (Jiný identifikátor: Janssen-Cilag International NV)
  • 2015-004203-24 (Číslo EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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