Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
2011년 5월 3일 업데이트: Pfizer
A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
80
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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Connecticut
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New Haven, Connecticut, 미국, 06511-5473
- Pfizer Investigational Site
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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:
- Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- Women of non-childbearing potential only.
- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
Exclusion Criteria:
- Previous antibiotic use within 14 days prior to dosing.
- Use of antibiotics during hospitalization within 90 days prior to dosing.
- History of sensitivity to macrolides or ketolides.
- Presence of clinically significant eye conditions (other than corrective lenses).
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: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 코호트 1
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 코호트 2
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 코호트 3
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 코호트 4
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 코호트 5
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 집단 6
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: 코호트 7
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: Cohort 8
Japanese volunteers, low dose previously tested (based on PK)
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: Cohort 9
Japanese volunteers, intermediate dose previously tested (based on PK)
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
실험적: Cohort 10
Japanese volunteers, high dose previously tested (based on safety)
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
기간: Daily up to discharge, follow-up 7-10 days after dosing
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Daily up to discharge, follow-up 7-10 days after dosing
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Pharmacokinetics of PF-04287881 after a single oral dose.
기간: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
|
Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
2008년 11월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2009년 12월 1일
연구 등록 날짜
최초 제출
2008년 11월 12일
QC 기준을 충족하는 최초 제출
2008년 11월 17일
처음 게시됨 (추정)
2008년 11월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 5월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 5월 3일
마지막으로 확인됨
2011년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- B0581001
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. .