HypertensionPhase 1NCT01104545

A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)

A Phase 1 study testing MK-3614 in people with Hypertension, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: MK-3614
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: No sites listed yet
Study dates: 1 Nov 2008to 1 May 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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.

Read the detailed description

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.

Conditions: Hypertension
Being tested: MK-3614, Comparator: Placebo
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-3614Drug
Comparator: PlaceboDrug

Study groups in NCT01104545
Study group	Role	What they receive
Panel A - Healthy	Experimental	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. Receives: Drug: MK-3614; Drug: Comparator: Placebo
Panel B - Healthy	Experimental	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 Receives: Drug: MK-3614; Drug: Comparator: Placebo
Panel C - Hypertensive	Experimental	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 Receives: Drug: MK-3614; Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants
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.
Measured: up to 7 days for each dose level
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants
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.
Measured: up to 7 days for each dose level
Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants
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.
Measured: up to 7 days for each dose level
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: Baseline and 24 hours post-dose for each dose level
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Change From Baseline in Heart Rate - Hypertensive Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants
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.
Measured: Baseline and 24 hours postdose for each dose level

Secondary outcomes (10)

Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants
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.
Measured: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants
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.
Measured: Baseline and 24 hours postdose for each dose level

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20081 May 2009

First posted15 Apr 2010 (estimated)
Study start1 Nov 2008
Primary completion1 May 2009
Study completion1 May 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01104545
Sponsor's protocol ID: 3614-001
Other IDs: MK-3614-001, 2010_525
Status last verified: Jun 2019
First submitted: 13 Apr 2010
Last updated: 8 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Recruiting
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-3614
ClinicalTrials.gov ID: NCT01104545
Acronym / sponsor ID: 3614-001
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Nov 2008 (actual)
Primary completion: 1 May 2009 (actual)
Study completion: 1 May 2009 (actual)
First posted: 15 Apr 2010 (estimated)
Results: Posted 8 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Panel A - Healthy	Experimental	Drug: MK-3614, Drug: Comparator: PlaceboHealthy 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.
Panel B - Healthy	Experimental	Drug: MK-3614, Drug: Comparator: PlaceboHealthy 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
Panel C - Hypertensive	Experimental	Drug: MK-3614, Drug: Comparator: PlaceboHypertensive 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

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-3614	Drug	Panel A - Healthy, Panel B - Healthy, Panel C - Hypertensive
Comparator: Placebo	Drug	Panel A - Healthy, Panel B - Healthy, Panel C - Hypertensive

Primary outcome

Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants
Time frame: 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.
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants
Time frame: 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.
Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants
Time frame: 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.
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants
Time frame: 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.
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants
Time frame: 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.
Maximum Concentration (Cmax) of MK-3614- Healthy Participants
Time frame: 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.
Time to Cmax (Tmax) of MK-3614- Healthy Participants
Time frame: 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.
Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants
Time frame: 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.
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants
Time frame: 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
Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants
Time frame: 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
Time to Cmax (Tmax) of MK-3614- Hypertensive Participants
Time frame: 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
Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants
Time frame: 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
Change From Baseline in Heart Rate - Healthy Participants
Time frame: 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.
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants
Time frame: 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.
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants
Time frame: 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.
Change From Baseline in Heart Rate - Hypertensive Participants
Time frame: 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.
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants
Time frame: 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.
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants
Time frame: 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.

10 secondary outcomes

Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
Time frame: 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
Time frame: 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
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants
Time frame: Baseline and 24 hours postdose for each dose level
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants
Time frame: Baseline and 24 hours postdose for each dose level

Results and safety

Results posted to the registry on 8 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A - Healthy	8	8
Panel B - Healthy	8	7
Panel C - Hypertensive	8	6

Primary outcome: Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants

Time frame: up to 7 days for each dose level. Number. Unit: Percentage of Participants

Measure	0.25 mg MK-3614 Panel A n = 6	1.25 mg MK-3614 Panel A n = 6	0.25 mg w/ Food MK-3614 Panel A n = 5	0.75 mg MK-3614 Panel A n = 6	Placebo Panel A n = 6	0.5 mg MK-3614 Panel B n = 6	0.75 mg MK-3614 Panel B n = 6	0.25 mg b.i.d. MK-3614 Panel B n = 5	0.25 mg t.i.d MK-3614 Panel B n = 5	Placebo Panel B n = 7
Value	100.0	100.0	80.0	33.3	66.7	66.7	66.7	20.0	60.0	57.1

Population analysed: All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.

Primary outcome: Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants

Time frame: up to 7 days for each dose level. Number. Unit: Percentage of Participants

Measure	0.25 mg MK-3614 Panel A n = 6	1.25 mg MK-3614 Panel A n = 6	0.25 mg w/ Food MK-3614 Panel A n = 5	0.75 mg MK-3614 Panel A n = 6	Placebo Panel A n = 6	0.5 mg MK-3614 Panel B n = 6	0.75 mg MK-3614 Panel B n = 6	0.25 mg b.i.d. MK-3614 Panel B n = 5	0.25 mg t.i.d MK-3614 Panel B n = 5	Placebo Panel B n = 7
Value	0.0	0.0	0.0	0.0	0.0	16.7	0.0	0.0	0.0	0.0

Population analysed: All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.

Primary outcome: Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants

Time frame: up to 7 days for each dose level. Number. Unit: Percentage of Participants

Measure	0.75 mg MK-3614 Panel C n = 8	0.5 mg MK-3614 Panel C n = 5	Placebo Panel C n = 7
Value	75.0	60.0	57.1

Population analysed: All participants in in Panel C who received at least 1 dose of study drug and had available data for endpoint.

Primary outcome: Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants

Time frame: up to 7 days for each dose level. Number. Unit: Percentage of Participants

Measure	0.75 mg MK-3614 Panel C n = 8	0.5 mg MK-3614 Panel C n = 5	Placebo Panel C n = 7
Value	12.5	0.0	14.3

Population analysed: All participants in in Panel C who received at least 1 dose of study drug and had available data for endpoint.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days postdose for each dose level (up to 15 weeks total). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.25 mg MK-3614 Panel A	0 of 6 (0%)	6 of 6 (100%)	0 of 6
1.25 mg MK-3614 Panel A	0 of 6 (0%)	6 of 6 (100%)	0 of 6
0.25 mg w/ Food MK-3614 Panel A	0 of 5 (0%)	4 of 5 (80%)	0 of 5
0.75 mg MK-3614 Panel A	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo Panel A	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
0.5 mg MK-3614 Panel B	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
0.75 mg MK-3614 Panel B	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
0.25 mg b.i.d. MK-3614 Panel B	0 of 5 (0%)	1 of 5 (20%)	0 of 5
0.25 mg t.i.d MK-3614 Panel B	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Placebo Panel B	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
0.75 mg MK-3614 Panel C	0 of 8 (0%)	6 of 8 (75%)	0 of 8
0.5 mg MK-3614 Panel C	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Placebo Panel C	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-3614 in people with Hypertension, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants (time frame: up to 7 days for each dose level). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01104545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.