A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
2016년 1월 22일 업데이트: Pfizer
A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
22
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, 10117
- 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
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months
Exclusion Criteria:
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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oral inhaled formulation, single dose
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활성 비교기: 활성 비교기
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oral inhaled formulation, single dose
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실험적: PF-03635659
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oral inhaled formulation, single dose, low dose
oral inhaled formulation, single dose, mid dose
oral inhaled formulation, single dose, high dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
기간: Baseline, 24, 24.5 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose.
Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period.
Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
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Baseline, 24, 24.5 hrs post-dose
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Maximum Observed Plasma Concentration (Cmax)
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Maximum Observed Plasma Concentration
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Plasma Decay Half-Life (t1/2)
기간: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Forced Expiratory Volume in 1 Second (FEV1)
기간: Baseline up to 48 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Peak FEV1 was defined as change from baseline in maximum FEV1.
Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose.
Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 48 hrs post-dose
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Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
기간: Baseline up to 24.5 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5.
Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 24.5 hrs post-dose
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Change From Baseline in Force Vital Capacity (FVC)
기간: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
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FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible.
Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in FVC was the difference between FVC and baseline FVC.
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Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
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Change From Baseline in Inspiratory Capacity (IC)
기간: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
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IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally.
Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in IC was the difference between IC and baseline IC.
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Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
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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
2010년 1월 1일
기본 완료 (실제)
2010년 6월 1일
연구 완료 (실제)
2010년 6월 1일
연구 등록 날짜
최초 제출
2009년 12월 15일
QC 기준을 충족하는 최초 제출
2009년 12월 15일
처음 게시됨 (추정)
2009년 12월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 1월 22일
마지막으로 확인됨
2016년 1월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- B0431010
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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