このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males

2012年5月4日 更新者：UCB Pharma

Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers

The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.

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)

16

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

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

男

説明

Inclusion Criteria:

  • Healthy male volunteers 18-55 years of age
  • BMI 18.0-30.0 kg/m2 and weight at least 50 kg
  • Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive

Exclusion Criteria:

  • Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
  • Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
  • Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
  • Volunteer has history of suicide attempt
  • Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months

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

  • 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：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
他の：Lacosamide
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
他の名前：
  • ビンパット
他の：Single dose of Warfarin
他の：Warfarin

Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period

In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.

Duration: single dose

他の名前：
  • クマディン

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
時間枠
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)
時間枠：Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Maximum Warfarin plasma concentration (Cmax)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Maximum prothrombin time (PTmax)
時間枠：Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)
時間枠：Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin maximum international normalized ratio (INRmax)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

二次結果の測定

結果測定
メジャーの説明
時間枠
Lacosamide trough plasma concentration (Ctrough)
時間枠：Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Time of maximum Warfarin plasma concentration (Tmax)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Terminal half-life of Warfarin (T ½)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent total body clearance of Warfarin (CL /F)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent volume of distribution of Warfarin (V /F)
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
First order terminal elimination rate constant of Warfarin
時間枠：Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
CYP2C9 genotype
時間枠：Single measurement on Day 1
Single measurement on Day 1
VKORC1 genotype
時間枠：Single measurement on Day 1
Single measurement on Day 1
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
時間枠：Duration of study is approximately 32 days
Duration of study is approximately 32 days
Change from Baseline in Pulse Rate at 4 h post dose
時間枠：From pre dose to 4 h post dose Warfarin administration in each treatment period
40-90 bpm
From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 12 h post dose
時間枠：From pre dose to 12 h post dose Warfarin administration in each treatment period
40-90 bpm
From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 24 h post dose
時間枠：From pre dose to 24 h post dose Warfarin administration in each treatment period
40-90 bpm
From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 4 h post dose
時間枠：From pre dose to 4 h post dose Lacosamide (LCM) administration
40-90 bpm
From pre dose to 4 h post dose Lacosamide (LCM) administration
Change from Baseline in Pulse Rate at 12 h post dose
時間枠：From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 4 h post dose
時間枠：From pre dose to 4 h post dose Warfarin administration in each treatment period
From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 12 h post dose
時間枠：From pre dose to 12 h post dose Warfarin administration in each treatment period
From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 24 h post dose
時間枠：From pre dose to 24 h post dose Warfarin administration in each treatment period
From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 4 h post dose
時間枠：From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 12 h post dose
時間枠：From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
時間枠：From pre dose to 4 h post dose Warfarin administration in each treatment period
From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
時間枠：From pre dose to 12 h post dose Warfarin administration in each treatment period
From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 24 h post dose
時間枠：From pre dose to 24 h post dose Warfarin administration in each treatment period
From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
時間枠：From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
時間枠：From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration
Change from Baseline in Body Temperature at 4h post dose
時間枠：From pre dose to 4 h post dose Warfarin administration in each treatment period
From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 12 h post dose
時間枠：From pre dose to 12 h post dose Warfarin administration in each treatment period
From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 24 h post dose
時間枠：From pre dose to 24 h post dose Warfarin administration in each treatment period
From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 4 h post dose
時間枠：From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Body Temperature at 12 h post dose
時間枠：From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration

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

UCB Pharma

捜査官

  • スタディディレクター：UCB Clinical Trial Call Center、1 877 822 9493

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

2012年1月1日

一次修了 (実際)

2012年3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

2012年1月31日

QC基準を満たした最初の提出物

2012年2月2日

最初の投稿 (見積もり)

2012年2月3日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年5月7日

QC基準を満たした最後の更新が送信されました

2012年5月4日

最終確認日

2012年5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

  • EP0013
  • 2011-004911-21 (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。

購読する