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머크A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005) 1상 39
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임상시험 NCT07431866은(는) 기초과학을(를) 알아보기 위한 연구입니다. 이 연구는 건강한에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 3월 18일에 시작되어 39명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2026년 6월 7일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 25일에 갱신되었습니다.
간단한 개요
Researchers are looking for other ways to treat people who have heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart becomes stiff and does not relax properly. MK-2828 is a study medicine designed to treat HFpEF.
The main goal of the study is to learn if MK-2828 affects what happens to rosuvastatin or furosemide in the body.
공식 제목
A Two-Part Clinical Study to Evaluate the Effect of Multiple Doses of MK-2828 on Rosuvastatin (Part 1) and Furosemide (Part 2) in Healthy Participants
질환명
건강한기타 연구 식별자
- 2828-005
NCT 번호
실제 연구 시작일
2026-03-18
최신 업데이트 게시
2026-03-25
예상 연구 완료일
2026-06-07
계획된 등록 인원
39
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
기초과학
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Rosuvastatin + MK-2828 Participants receive rosuvastatin and MK-2828 orally. | Rosuvastatin Oral administration MK-2828 Oral administration |
실험적Furosemide + MK-2828 Participants receive furosemide and MK-2828 orally. | Furosemide Oral administration MK-2828 Oral administration |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin | Blood samples will be collected to determine the AUC0-inf of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Furosemide | Blood samples will be collected to determine the AUC0-inf of furosemide. | At designated time points (up to approximately 2 weeks) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 1 month |
Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in who discontinue study treatment due to an AE will be reported. | Up to approximately 2 weeks |
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Rosuvastatin | Blood samples will be collected to determine the AUC0-last of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Furosemide | Blood samples will be collected to determine the AUC0-last of furosemide. | At designated time points (up to approximately 2 weeks) |
Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Rosuvastatin | Blood samples will be collected to determine the AUC0-24 of rosuvastatin. | At designated time points (up to approximately 24 hours) |
Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Furosemide | Blood samples will be collected to determine the AUC0-24 of furosemide. | At designated time points (up to approximately 24 hours) |
Maximum Plasma Concentration (Cmax) of Rosuvastatin | Blood samples will be collected to determine the Cmax of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Maximum Plasma Concentration (Cmax) of Furosemide | Blood samples will be collected to determine the Cmax of furosemide. | At designated time points (up to approximately 2 weeks) |
Time of the Maximum Plasma Concentration (Tmax) of Rosuvastatin | Blood samples will be collected to determine the Tmax of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Time of the Maximum Plasma Concentration (Tmax) of Furosemide | Blood samples will be collected to determine the Tmax of furosemide. | At designated time points (up to approximately 2 weeks) |
Terminal Half-life (t1/2) of Rosuvastatin | Blood samples will be collected to determine the t1/2 of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Terminal Half-life (t1/2) of Furosemide | Blood samples will be collected to determine the t1/2 of furosemide. | At designated time points (up to approximately 2 weeks) |
Apparent Total Plasma Clearance (CL/F) of Rosuvastatin | Blood samples will be collected to determine the CL/F of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Apparent Total Plasma Clearance (CL/F) of Furosemide | Blood samples will be collected to determine the CL/F of furosemide. | At designated time points (up to approximately 2 weeks) |
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Rosuvastatin | Blood samples will be collected to determine the Vz/F of rosuvastatin. | At designated time points (up to approximately 2 weeks) |
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Furosemide | Blood samples will be collected to determine the Vz/F of furosemide. | At designated time points (up to approximately 2 weeks) |
참여 도우미
적격성 기준
연령대
성인
최소 연령
24 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2
The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
1 1개국에 임상시험 장소
Florida
Fortrea Clinical Research Unit Inc ( Site 0001), Daytona Beach, Florida, 32117, United States
Study Coordinator, 연락처, 386-366-6414
모집중