이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

2019년 3월 5일 업데이트: Pfizer

A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

연구 개요

연구 유형

중재적

등록 (실제)

6

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Groningen, 네덜란드, 9728 NZ
        • PRA Health Sciences
      • Utrecht, 네덜란드, 3584 BL
        • PRA Health Sciences Utrecht

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

아니

연구 대상 성별

남성

설명

Exclusion Criteria:

  • Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
  • Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
  • Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
  • Use of herbal supplements within 28 days prior to the first dose of study medication
  • Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Pfizer
  • Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
  • Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.

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: 무작위화되지 않음
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 2-period, fixed sequence
fixed sequence with 2 treatment period
Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
60 mg unlabeled PF-06700841 oral dose in 2nd period
30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
mass balance_urine
기간: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
hour 0 up to 312 hours post dose
mass balance_feces
기간: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
hour 0 up to 312 hours post dose

2차 결과 측정

결과 측정
측정값 설명
기간
metabolite identification_plasma
기간: hour 0 up to 312 hours post dose
metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Cmax for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Tmax for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma AUClast for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma AUCinf for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
Oral clearance for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma half-life for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
volume of distribution for total 14C radioactivity
기간: hour 0 up to 312 hours post dose
apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Cmax for PF-06700841
기간: hour 0 up to 96 hours post dose
maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma Tmax for PF-06700841
기간: hour 0 up to 96 hours post dose
time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUClast for PF-06700841
기간: hour 0 up to 96 hours post dose
area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUCinf for PF-06700841
기간: hour 0 up to 96 hours post dose
area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
Oral clearance for PF-06700841
기간: hour 0 up to 96 hours post dose
oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma half-life for PF-06700841
기간: hour 0 up to 96 hours post dose
half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
volume of distribution for PF-06700841
기간: hour 0 up to 96 hours post dose
apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma Cmax for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma Tmax for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUClast for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUCinf for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
clearance for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma half-life for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
volume of distribution for 14C-labeled PF-06700841
기간: hour 0 up to 96 hours post dose
volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
unchanged PF-06700841 recovered in urine
기간: hour 0 up to 96 hours post dose
percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841
hour 0 up to 96 hours post dose
renal clearance of PF-06700841
기간: hour 0 up to 96 hours post dose
renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)
hour 0 up to 96 hours post dose
Bioavailability of oral PF-06700841
기간: hour 0 up to 96 hours post dose
Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841
hour 0 up to 96 hours post dose
Fraction absorbed of oral PF-06700841
기간: hour 0 up to 144 hours post dose
Fraction absorbed in gut (Fa) following oral dose of PF-06700841
hour 0 up to 144 hours post dose
metabolite identification_urine
기간: hour 0 up to 312 hours post dose
metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
metabolite identification_feces
기간: hour 0 up to 312 hours post dose
metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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 (실제)

2018년 12월 10일

기본 완료 (실제)

2019년 2월 21일

연구 완료 (실제)

2019년 2월 21일

연구 등록 날짜

최초 제출

2018년 12월 6일

QC 기준을 충족하는 최초 제출

2018년 12월 6일

처음 게시됨 (실제)

2018년 12월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 5일

마지막으로 확인됨

2019년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • B7931014
  • 2018-002403-34 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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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