A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
2026년 9월 2일 업데이트: Merck Sharp & Dohme LLC
An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
연구 개요
상태
상태
모집하지 않고 적극적으로
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
44
단계
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.com
연구 장소
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Florida
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Daytona Beach, Florida, 미국, 32117
- Fortrea Clinical Research Unit Inc ( Site 0001)
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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
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Be in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
- Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- Has a history of cancer (malignancy)
- Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)
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: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
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구강 정제
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실험적: Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
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구강 정제
Oral tablet
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실험적: Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
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구강 솔루션
구강 정제
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 1: Number of Participants Who Experience an Adverse Event (AE)
기간: Up to approximately 43 days
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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 AE will be reported.
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Up to approximately 43 days
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Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 43 days
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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 discontinue study treatment due to an AE will be reported.
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Up to approximately 43 days
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Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
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Part 2: Tmax of MK-8527 in Plasma with and without Probenecid
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
|
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Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
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Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid
기간: Predose and at designated timepoints (up to 336 hours postdose)
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Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
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Predose and at designated timepoints (up to 336 hours postdose)
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Part 2: Urine Concentration at 72 Hours of MK-8527
기간: At designated timepoints (up to 72 hours postdose)
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Urine samples will be collected to estimate the urine concentration of MK-8527.
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At designated timepoints (up to 72 hours postdose)
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Part 2: Renal Clearance of MK-8527
기간: At designated timepoints (up to 72 hours postdose)
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Urine samples will be collected to estimate the renal clearance of MK-8527.
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At designated timepoints (up to 72 hours postdose)
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Part 2: Number of Participants Who Experience an AE
기간: Up to approximately 43 days
|
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 AE will be reported.
|
Up to approximately 43 days
|
|
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 43 days
|
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 discontinue study treatment due to an AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole
기간: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Urine Concentration at 72 Hours of MK-8527
기간: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Renal Clearance of MK-8527
기간: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the renal clearance of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Number of Participants Who Experience an AE
기간: Up to approximately 43 days
|
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 AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 43 days
|
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 discontinue study treatment due to an AE will be reported.
|
Up to approximately 43 days
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
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 (실제)
연구 시작
2026년 6월 30일
기본 완료 (추정된)
기본 완료
2026년 10월 9일
연구 완료 (추정된)
연구 완료
2026년 10월 9일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 8527-021
- MK-8527-021 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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. .