- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00982553
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers
연구 개요
상세 설명
Phase I (study day 1 - 14):
- 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled.
- On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.
- This will be followed by a wash-out period.
- As steady state pharmacokinetics of ribavirin are not reached for several weeks, single dosing pharmacokinetics will be assessed in this study
Phase II (study days 15 - 19):
- On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend for safety visits and witnessed dosing during this phase.
- Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached, subjects will attend for a 12 hour detailed pharmacokinetic visit where following witnessed administration of raltegravir 400 mg without food, blood sampling will be drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment of raltegravir plasma exposure.
Phase III (study day 20):
• Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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London, 영국, W2 1NY
- Imperial College Healthcare NHS Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- Male or non-pregnant, non-lactating female.
- Between 18 to 60 years, inclusive.
- Subjects in good health upon medical history, physical exam, and laboratory testing and body mass index below 32.
Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 180 days following last dose of study drug:
- barrier contraceptives (condom, diaphragm with spermicide)
- oral combined contraceptive pill, implant or injectable hormonal contraceptive PLUS a barrier contraceptive
- Intrauterine device (IUD) or intrauterine system (IUS) PLUS a barrier contraceptive (or a partner who has been vasectomized for at least six months).
- Female subjects of childbearing potential must have a negative urine pregnancy test.
- Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 180 days following last dose of study drug.
- Have no serologic evidence of HIV infection.
- Have no serologic evidence of active hepatitis B virus infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection through antibody testing.
- Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance.
Exclusion Criteria:
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
- Have a body mass index (BMI) greater than 32
- Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
- Clinically relevant alcohol or drug use (positive screening drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- Any medication taken listed in Prior and Concomitant Medication section including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol and/or hormonal contraceptives including the combined oral contraceptive pill, Depo-Provera and the Mirena intrauterine system. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
- History of drug sensitivity or drug allergy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Phase 1_ribavirin
Treatment with Single dose ribavirin (800 mg) administered on day 1
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800mg once daily
다른 이름들:
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실험적: Phase2_raltegravir
Treatment with Raltegravir (400 mg twice daily) administered from days 15-19
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1일 2회 400mg
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실험적: Phase3_ribavirin+raltegravir
Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20
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1일 2회 400mg
800mg once daily
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Ribavirin Maximum Plasma Concentration
기간: Day 20
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Pharmacokinetic analyses of blood samples
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Day 20
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Raltegravir Maximum Plasma Concentration
기간: Day 20
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Day 20
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Ribavirin Minimum Plasma Concentration
기간: Day 20
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Ribavirin minimum plasma concentration by pharmacokinetic analyses
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Day 20
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Raltegravir Minimum Plasma Concentrations
기간: Day 20
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Raltegravir minimum plasma concentrations by pharmacokinetic analyses
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Day 20
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alan Winston, MB BH, Imperial College London
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2009-010005-36 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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