A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
2016년 3월 1일 업데이트: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.
연구 개요
연구 유형
중재적
등록 (실제)
40
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Brussels, 벨기에, B-1070
- Pfizer Clinical Research Unit
-
-
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:
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
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
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
실험적: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
실험적: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
실험적: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
실험적: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
실험적: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Assessment of adverse events (AEs).
기간: 0-25 days
|
0-25 days
|
|
Assessment of clinical laboratory tests.
기간: 0-25 days
|
0-25 days
|
|
Assessment of vital signs (including blood pressure and pulse rate).
기간: 0-25 days
|
0-25 days
|
|
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
기간: 0-25 days
|
0-25 days
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12 hours post dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
기간: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12 hours post dose
|
|
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
기간: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0- tau hours post dose
|
0- tau hours post dose
|
|
Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0- tau hours post dose
|
0- tau hours post dose
|
|
Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
기간: 0- tau hours post dose
|
0- tau hours post dose
|
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
2015년 3월 1일
기본 완료 (실제)
2016년 2월 1일
연구 완료 (실제)
2016년 2월 1일
연구 등록 날짜
최초 제출
2015년 3월 12일
QC 기준을 충족하는 최초 제출
2015년 3월 12일
처음 게시됨 (추정)
2015년 3월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 3월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 1일
마지막으로 확인됨
2016년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- B7871002
- 2015-000130-29 (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. .
PF-06427878에 대한 임상 시험
-
Pfizer완전한