Dosing Obese With Noxafil® Under a Trial (DONUT) (DONUT)
Pharmacokinetics of Posaconazole Given as a Single Intravenous Dose to Obese Subjects: Dosing Obese With Noxafil® Under a Trial (DONUT)
Although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified. There is clear evidence indicating that heavier patients are receiving a sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented prevalence of species with intermediate susceptible to posaconazole, adequate dosing is needed at start of treatment.
Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
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Nieuwegein, 네덜란드
- St. Antonius Hospital
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Nijmegen, 네덜란드
- Radboudumc
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Subjects BMI:
- obese groups: subject must have a BMI ≥35 kg/m2 at the time of inclusion,
- non-obese group: subject must have a BMI ≥18.5 and < 25kg/m2 at the time of inclusion.
- Subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing;
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant;
Subject is able and willing to sign the Informed Consent before screening evaluations.
For the non-obese subjects the following additional inclusion criteria applies:
- Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, hematology and urinalysis testing within 6 weeks prior to study drug administration. Results of biochemistry, hematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included based on the investigator's judgment that the observed deviations are not clinically relevant. This should be clearly recorded;
Exclusion Criteria:
- Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation;
- History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
- Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration.
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration;
- Blood transfusion within 8 weeks prior to study drug administration;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Obese subjects
Subjects with a BMI>35 kg/m2
|
Single dose by intravenous infusion 300mg
Single dose by intravenous infusion 400mg
|
|
활성 비교기: Non-obese subjects
Subjects with a BMI>18.5 and <25 kg/m2
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Single dose by intravenous infusion 300mg
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Posaconazole exposure
기간: Through study completion (usually after 24 or 48 hours)
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The concentration-time curve of posaconazole in obese will be compared with that in non-obese subjects.
Exposure is assessed by Area-Under-the-Curve from zero to 48 hours (AUC0-48h).
|
Through study completion (usually after 24 or 48 hours)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Exposure with augemented posaconazol dose
기간: Through study completion (usually after 24 or 48 hours)
|
The concentration-time curve of posaconazole in obese receiving 400mg will be compared with that in non-obese subjects.
Exposure is assessed by Area-Under-the-Curve from zero to 48 hours (AUC0-48h).
|
Through study completion (usually after 24 or 48 hours)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Roger Brüggemann, PhD-PharmD, Radboud University Medical Center
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UMCN-AKF-17.08
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
미국에서 제조되어 미국에서 수출되는 제품
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