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
2016年3月23日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
36
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Leiden、オランダ
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年11月1日
一次修了 (実際)
2016年2月1日
研究の完了 (実際)
2016年2月1日
試験登録日
最初に提出
2015年10月15日
QC基準を満たした最初の提出物
2015年10月15日
最初の投稿 (見積もり)
2015年10月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月24日
QC基準を満たした最後の更新が送信されました
2016年3月23日
最終確認日
2016年3月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CR108056
- 42847922EDI1011 (その他の識別子：Janssen-Cilag International NV)
- 2015-004203-24 (EudraCT番号)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。