A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
2014년 9월 23일 업데이트: Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (예상)
86
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
- 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:
- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.
Exclusion Criteria:
- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 2
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
위약 비교기: 1
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
위약 비교기: 4
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1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
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위약 비교기: 삼
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Placebo for PF-06252616, IV infusion, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, IV infusion, repeat dose
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
위약 비교기: 6
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1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
위약 비교기: 7
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1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
위약 비교기: 5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
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1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of treatment related Adverse Events.
기간: Day 197
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Day 197
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Severity of treatment related Adverse Events.
기간: Day 197
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Day 197
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Incidence of abnormal lab findings.
기간: Day 197
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Day 197
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Magnitude of abnormal lab findings.
기간: Day 197
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Day 197
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Abnormal and clinically relevant changes in Blood Pressure.
기간: Day 197
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Day 197
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Abnormal and clinically relevant changes in Pulse Rate.
기간: Day 197
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Day 197
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Abnormal and clinically relevant changes in Respiratory Rate.
기간: Day 197
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Day 197
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Abnormal and clinically relevant changes in temperature.
기간: Day 197
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Day 197
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Abnormal and clinically relevant changes in ECG parameters.
기간: Day 197
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Day 197
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
기간: Through Day 113 post dosing
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Through Day 113 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
기간: Through Day 197 post dosing
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Through Day 197 post dosing
|
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Steady state volume of distribution is the apparent volume of distribution at steady-state.)
기간: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
기간: Through Day 197 post dosing
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Through Day 197 post dosing
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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
2012년 6월 1일
기본 완료 (실제)
2014년 8월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2012년 5월 25일
QC 기준을 충족하는 최초 제출
2012년 6월 7일
처음 게시됨 (추정)
2012년 6월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 23일
마지막으로 확인됨
2014년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- B5161001
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-06252616에 대한 임상 시험
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Pfizer종료됨
-
Pfizer완전한