The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
2016년 5월 6일 업데이트: Pfizer
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers
The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.
연구 개요
연구 유형
중재적
등록 (실제)
37
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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Michigan
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Kalamazoo, Michigan, 미국, 49007
- Jasper Clinic, Inc.
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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:
- Healthy male or females willing to be confined and comply with scheduled visits
- Women are to be surgically sterile.
Exclusion Criteria:
- History of febrile illness within 5 days prior to the first dose
- Positive urine drug screen
- Treatment with an investigational product within 30 days prior to the first dose of study medication
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: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
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Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
다른: Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
다른: Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
다른: Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
다른: Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
다른: Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
다른: Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
기간: 8 days
|
The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
기간: 8 days
|
Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
기간: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
|
Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
|
14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
기간: 8 days
|
Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
기간: 8 days
|
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1)
기간: 8 days
|
Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
기간: 8 days
|
Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
기간: Day 6
|
On Day 6 of each period, subjects will undergo an oral glucose tolerance test.
After ingesting 75 g of a glucose solution within 5 minutes of receiving their daily dose of prednisone, blood samples for glucose were obtained at 0.5, 1 and 2 hours.
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Day 6
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
기간: 8 days
|
Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
기간: 7 days
|
Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
|
7 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
기간: 8 days
|
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
기간: 7 days
|
Change from baseline after 7 days of treatment in each treatment period.
The POMS is a copyrighted questionnaire that measures 6 dimensions of mood.
The subject will assess how 65 descriptors apply to him/her on a 5-point scale of 0 (not at all) to 4 (extremely).
|
7 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
기간: 7 days
|
Change from baseline in sleep after 7 days of treatment will be assessed in each treatment period.
The patient-reported questionnaire consists of 12 items that assesses the key constructs of sleep.
Scores can range from 12-71 with higher number indicating more problems with sleep.
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7 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
기간: 28 days after last dose of study medication in Period 3
|
Subjects were monitored throughout the study and queried for adverse events
|
28 days after last dose of study medication in Period 3
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
기간: 8 days
|
Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
기간: 8 days
|
A post-void weight will be collected on the morning of Day 1 and Day 8 to assess change from baseline during each treatment period.
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
기간: 8 days
|
Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
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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
2005년 10월 1일
기본 완료 (실제)
2006년 3월 1일
연구 완료 (실제)
2006년 3월 1일
연구 등록 날짜
최초 제출
2016년 4월 21일
QC 기준을 충족하는 최초 제출
2016년 5월 6일
처음 게시됨 (추정)
2016년 5월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 5월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 5월 6일
마지막으로 확인됨
2016년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A9001309
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