A Multiple Dose Study Of PF-06678552 In Healthy Subjects
2014년 7월 29일 업데이트: Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects
PF-06678552 is a new compound proposed for the treatment of hypercholesteremia.
The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
38
단계
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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Brussels, 벨기에, B-1070
- 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
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential.
- Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
- Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
6
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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실험적: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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실험적: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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실험적: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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실험적: Cohort 5
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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실험적: Cohort 6
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
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Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
기간: 0 to 24 days post dose
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0 to 24 days post dose
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Amount of PF-06644927 excreted in urine (Ae) on day 14
기간: 0-12 hours post dose
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0-12 hours post dose
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Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
기간: 0-12 hours post dose
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0-12 hours post dose
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Renal clearance of PF-06644927 (CLr) on day 14
기간: 0-12 hours post dose
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0-12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Apparent Oral Clearance (CL/F) of PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14
기간: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
연구 시작
2014년 3월 1일
기본 완료 (실제)
기본 완료
2014년 7월 1일
연구 완료 (실제)
연구 완료
2014년 7월 1일
연구 등록 날짜
최초 제출
최초 제출
2014년 3월 4일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2014년 3월 4일
처음 게시됨 (추정)
처음 게시됨
2014년 3월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
2014년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2014년 7월 29일
마지막으로 확인됨
마지막으로 확인됨
2014년 7월 1일
추가 정보
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. .