건강한 성인 참가자(MK-8507-016)를 대상으로 한 MK-8507 및 이슬라트라비르(MK-8591)에 대한 연구
건강한 성인 참가자를 대상으로 MK-8507의 주간 다중 투여와 이슬라트라비르(MK-8591)의 단일 투여 사이의 양방향 상호작용을 평가하기 위한 공개 라벨 연구
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Nebraska
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Lincoln, Nebraska, 미국, 68502
- Celerion (Site 0001)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- 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 cancer with protocol specified exceptions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
Oral administration Oral administration
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Maximum Concentration (Cmax) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Time to Maximum Concentration (Tmax) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
기간: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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AUC0-Inf of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of Islatravir
기간: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
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Cmax of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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C168 of Islatravir
기간: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
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Tmax of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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t1/2 of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
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Apparent clearance (CL/F) of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
기간: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of MK-8507
기간: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
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Cmax of MK-8507
기간: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
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C168 of MK-8507
기간: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
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Tmax of MK-8507
기간: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
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t1/2 of MK-8507
기간: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the t1/2 of MK-8507. |
At designated timepoints (up to approximately 15 days)
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CL/F of MK-8507
기간: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
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Vd/F of MK-8507
기간: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Who Experience an Adverse Event (AE)
기간: Up to approximately 5 months
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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 an AE will be reported. |
Up to approximately 5 months
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Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 5 months
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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. |
Up to approximately 5 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 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 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. .