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Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

2015年9月29日 更新者：Otsuka Pharmaceutical Development & Commercialization, Inc.

A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold:

  • To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo
  • To determine the effect of moxifloxacin on QTcI
  • To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

218

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

  • アメリカ
    • California
      • Long Beach、California、アメリカ、90806
        • Otsuka Investigational Site
      • San Diego、California、アメリカ、92102
        • Otsuka Investigational Site
    • Florida
      • Fort Lauderdale、Florida、アメリカ、33308
        • Otsuka Investigational Site
    • Kansas
      • Overland Park、Kansas、アメリカ、66212
        • Otsuka Investigational Site
    • Maryland
      • Rockville、Maryland、アメリカ、20850
        • Otsuka Investigational Site
    • Missouri
      • St. Louis、Missouri、アメリカ、63118
        • Otsuka Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19139
        • Otsuka Investigational Site
    • Texas
      • Austin、Texas、アメリカ、78754
        • Otsuka Investigational Site

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

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.
  • Body mass index of 19 to 35 kg/m2.

Exclusion Criteria:

  • Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.
  • Subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator.
  • Subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout.
  • Subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.
  • Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.
  • Hospitalization for an exacerbation of schizophrenia or schizoaffective disorder within 3 months prior to randomization.
  • Subjects who have a history of or who have evidence of other medical and/or neurological conditions that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial.
  • Subjects with a history of neuroleptic malignant syndrome.
  • Subjects with a history of seizure disorder.
  • Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to randomization.

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：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Arm 1 (OPC-34712, placebo)
Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day.
薬：OPC-34712 (4mg)
Arms assigned to this intervention receive 4mg.
薬：Placebo
OPC-34712 placebo
アクティブコンパレータ：Arm 2 (OPC-34712, placebo)
Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day.
薬：Placebo
OPC-34712 placebo
薬：OPC-34712 (12mg)
Arms assigned to this intervention receive 12mg.
アクティブコンパレータ：Arm 3 (moxifloxacin, placebo)
Arm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days.
薬：Placebo
OPC-34712 placebo
薬：Moxifloxacin
Arms assigned to this intervention will receive 400mg.
アクティブコンパレータ：Arm 4 (moxifloxacin, placebo)
Arm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day.
薬：Placebo
OPC-34712 placebo
薬：Moxifloxacin
Arms assigned to this intervention will receive 400mg.

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
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
時間枠：Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
時間枠：AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication
Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.
AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication
Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.
時間枠：Day 11
Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Day 11
Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.
時間枠：Day 11
Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Day 11
Area Under the Plasma Concentration-time Curve During Dosing (AUCT).
時間枠：Day 11
Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Day 11

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
時間枠：Baseline, Day 11
New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day -1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).
時間枠：Baseline, Day 11
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.
Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).
時間枠：Baseline, Day 11
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.
Baseline, Day 11
Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.
時間枠：Day 11
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.
Day 11
Number of Participants With QTcI Interval > 60 Msec on Day 11.
時間枠：Day 11
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.
Day 11
Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.
時間枠：Day 11
The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.
Day 11
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
時間枠：Day 11
Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.
Day 11
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
時間枠：Day 11
Changes in HR with values 25% decrease from Day -1 and HR < 50 bpm and 25% increase from Day -1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day -1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day -1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.
Day 11

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。

スポンサー

Otsuka Pharmaceutical Development & Commercialization, Inc.

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

2011年7月1日

一次修了 (実際)

2012年2月1日

研究の完了 (実際)

2012年3月1日

試験登録日

最初に提出

2011年8月8日

QC基準を満たした最初の提出物

2011年8月25日

最初の投稿 (見積もり)

2011年8月26日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年10月29日

QC基準を満たした最後の更新が送信されました

2015年9月29日

最終確認日

2015年9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

  • 331-10-242

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。

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