A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
24. června 2019 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
24
Fáze
Fáze
- Fáze 1
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Mužský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
3
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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.
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Experimentální: 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
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Experimentální: 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
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants
Časové okno: up to 7 days for each dose level
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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.
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up to 7 days for each dose level
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Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants
Časové okno: 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.
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up to 7 days for each dose level
|
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Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants
Časové okno: 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
|
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Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants
Časové okno: 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
|
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Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants
Časové okno: 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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Maximum Concentration (Cmax) of MK-3614- Healthy Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Time to Cmax (Tmax) of MK-3614- Healthy Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Time to Cmax (Tmax) of MK-3614- Hypertensive Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants
Časové okno: Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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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
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Change From Baseline in Heart Rate - Healthy Participants
Časové okno: Baseline and 24 hours post-dose for each dose level
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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.
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Baseline and 24 hours post-dose for each dose level
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Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Change From Baseline in Heart Rate - Hypertensive Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants
Časové okno: 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
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Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
Časové okno: 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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Maximum Concentration (Cmax) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
Časové okno: 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.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Healthy Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants
Časové okno: Baseline and 24 hours postdose for each dose level
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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.
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Baseline and 24 hours postdose for each dose level
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Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants
Časové okno: 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
|
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Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants
Časové okno: 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
|
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Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
1. listopadu 2008
Primární dokončení (Aktuální)
Primární dokončení
1. května 2009
Dokončení studie (Aktuální)
Dokončení studie
1. května 2009
Termíny zápisu do studia
První předloženo
První předloženo
13. dubna 2010
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
13. dubna 2010
První zveřejněno (Odhad)
První zveřejněno
15. dubna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
8. srpna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. června 2019
Naposledy ověřeno
Naposledy ověřeno
1. června 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 3614-001
- MK-3614-001 (Jiný identifikátor: Merck)
- 2010_525
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .