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
2016년 3월 23일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
36
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Leiden, 네덜란드
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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실험적: 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.
|
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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실험적: 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.
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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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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Lateral Position (MLP) Assessed From an On-road Driving Test
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 11월 1일
기본 완료 (실제)
2016년 2월 1일
연구 완료 (실제)
2016년 2월 1일
연구 등록 날짜
최초 제출
2015년 10월 15일
QC 기준을 충족하는 최초 제출
2015년 10월 15일
처음 게시됨 (추정)
2015년 10월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 3월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 23일
마지막으로 확인됨
2016년 3월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR108056
- 42847922EDI1011 (기타 식별자: Janssen-Cilag International NV)
- 2015-004203-24 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
JNJ-42847922에 대한 임상 시험
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Janssen Research & Development, LLC완전한
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Janssen Research & Development, LLC모병
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Janssen Research & Development, LLC완전한
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Janssen Research & Development, LLC완전한