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

2012년 5월 4일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

16

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

남성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
다른: Lacosamide
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
다른 이름들:
  • 빔팟
다른: Single dose of Warfarin
다른: 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

다른 이름들:
  • 쿠마딘

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Lacosamide trough plasma concentration (Ctrough)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: Single measurement on Day 1
Single measurement on Day 1
VKORC1 genotype
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UCB Pharma

수사관

  • 연구 책임자: UCB Clinical Trial Call Center, 1 877 822 9493

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

2012년 1월 1일

기본 완료 (실제)

2012년 3월 1일

연구 완료 (실제)

2012년 3월 1일

연구 등록 날짜

최초 제출

2012년 1월 31일

QC 기준을 충족하는 최초 제출

2012년 2월 2일

처음 게시됨 (추정)

2012년 2월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 5월 4일

마지막으로 확인됨

2012년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EP0013
  • 2011-004911-21 (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. .

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