A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
2019년 6월 24일 업데이트: Merck Sharp & Dohme LLC
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-3614
This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.
연구 개요
상세 설명
Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled.
In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo.
All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing.
Panel A will begin first.
At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose.
In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo.
For all panels, there will be at least 7 days washout between treatment periods for any given participant.
Participants may only be enrolled in one panel of the study.
All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another.
As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.
연구 유형
중재적
등록 (실제)
24
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- Healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
- Participant is in good general health
- Participant is a nonsmoker
Exclusion Criteria:
- Participant has a history of stroke, seizure or major neurological disease
- Participant has functional disability that can interfere with rising from a sitting position to a standing position
- Participant has a family history of a bleeding or clotting disorder
- Participant has a history of cancer
- Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Participant consumes excessive amounts of alcohol or caffeine
- Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Panel A - Healthy
Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo.
There is at least a 7-day washout between the 4 dosing periods.
All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a high-fat breakfast.
|
|
|
실험적: Panel B - Healthy
Healthy participants receive single oral dose of MK-3614 0.5 mg.
0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo.
There is at least a 7-day washout between the 4 dosing periods.
All doses were administered after an 8-hour fast
|
|
|
실험적: Panel C - Hypertensive
Hypertensive participants receive single oral dose of MK-3614 0.75 mg.
0.5 mg.
0.75 mg, 0.75 mg or matching placebo.
There is at least a 7-day washout between the 4 dosing period.
All doses were administered after an 8-hour fast
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants
기간: up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants that reported at least 1 AE was summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants
기간: up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants who were discontinued from the study due to an AE were summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants
기간: up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants that reported at least 1 AE was summarized.
The percentage of participants that reported at least 1 AE was summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants
기간: up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants who were discontinued from the study due to an AE were summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Maximum Concentration (Cmax) of MK-3614- Healthy Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Time to Cmax (Tmax) of MK-3614- Healthy Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Time to Cmax (Tmax) of MK-3614- Hypertensive Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Change From Baseline in Heart Rate - Healthy Participants
기간: Baseline and 24 hours post-dose for each dose level
|
Heart rate measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours post-dose for each dose level
|
|
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Heart Rate - Hypertensive Participants
기간: Baseline and 24 hours postdose for each dose level
|
HR measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequence.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants
기간: Baseline and 24 hours postdose for each dose level
|
Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequence.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants
기간: Baseline and 24 hours postdose for each dose level
|
Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequnce.
|
Baseline and 24 hours postdose for each dose level
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of 0.25 mg MK-3614 in healthy participant when administered after an 8 hour fast and after a high-fat breakfest.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Maximum Concentration (Cmax) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
기간: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of 0.25 mg MK-3614 when administered after an 8 hour fast and after a high-fat breakfest.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery.
The change from baseline at 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants
기간: Baseline and 24 hours postdose for each dose level
|
Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery.
The change from baseline at 24 hours postdose was summarized.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device.
Change in bleeding time from baseline at 24 hours postdose were to be summarized.
Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants
기간: Baseline and 24 hours postdose for each dose level
|
Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device.
Change in bleeding time from baseline at 24 hours postdose were to be summarized.
Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose.
The change in cyclic GMP at 24 hours postdose was summarized.
Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants
기간: Baseline and 24 hours postdose for each dose level
|
Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose.
The change in cyclic GMP at 24 hours postdose was summarized.
Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants
기간: Baseline and 24 hours postdose for each dose level
|
Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose.
Percent inhibition from baseline at 24 hours postdose was calculated.
Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants
기간: Baseline and 24 hours postdose for each dose level
|
Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose.
Percent inhibition from baseline at 24 hours postdose was calculated.
Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
|
Baseline and 24 hours postdose for each dose level
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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)
2008년 11월 1일
기본 완료 (실제)
2009년 5월 1일
연구 완료 (실제)
2009년 5월 1일
연구 등록 날짜
최초 제출
2010년 4월 13일
QC 기준을 충족하는 최초 제출
2010년 4월 13일
처음 게시됨 (추정)
2010년 4월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 24일
마지막으로 확인됨
2019년 6월 1일
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. .
대조약: 위약에 대한 임상 시험
-
Anglia Ruskin UniversityDanone Global Research & Innovation Center완전한
-
Longhua HospitalShanghai University of Traditional Chinese Medicine; DongE E Jiao Coporation Limited; Innovation... 그리고 다른 협력자들아직 모집하지 않음
-
Universitas Sebelas MaretDexa Medica Group아직 모집하지 않음
-
University of PadovaDepartment of Neuroscience, University of Padova완전한
-
Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
-
Chiesi Farmaceutici S.p.A.아직 모집하지 않음
-
Nature's Sunshine Products, Inc.아직 모집하지 않음