HypertensionPhase 1NCT01096160

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)

A Phase 1 study testing MK-8226 BID, 1 mg, MK-8266 BID, 1.8 mg and MK-8266 TID, 1.8 mg 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.

Official record

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Trial summary

This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension. Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Hypertension
What is being tested?: MK-8226 BID, 1 mg, MK-8266 BID, 1.8 mg and MK-8266 TID, 1.8 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: 1 Mar 2010to 1 Nov 2010
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
No healthy volunteers
Adult

Who may be able to join

Participant is male with essential hypertension (high blood pressure)
Participant is in good general health (with the exception of hypertension)
Participant has a Body Mass Index (BMI) <= 33 kg/m^2 at the Screening visit
Participant has a platelet count >= 150,000 cu/mL at the Screening visit
Participant has a positive AIx at the Screening visit

Who cannot join

Participant has a history of stroke, chronic seizure, or major neurological disease
Participant has a functional disability that can interfere with rising from a seated position to the standing position
Participant has any 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
Participant consumes excessive amounts of alcohol or caffeinated beverages daily

About this study

Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8266

This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.

Read the detailed description

This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.

Conditions: Hypertension
Being tested: MK-8226 BID, 1 mg, MK-8266 BID, 1.8 mg, MK-8266 TID, 1.8 mg, MK-8266 TID, 2.4 mg, Placebo BID (Panel A)
Keywords: Hypertension
Medical subject headings: Hypertension

What participants receive

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

MK-8226 BID, 1 mgDrug
Also called MK-8266
MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
MK-8266 BID, 1.8 mgDrug
Also called MK-8266
MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
MK-8266 TID, 1.8 mgDrug
Also called MK-8266
MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
MK-8266 TID, 2.4 mgDrug
Also called MK-8266
MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
MK-8266 TID, 2.4 mgDrug
Also called MK-8266
MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Placebo BID (Panel A)Drug
Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
Placebo BID (Panel B)Drug
Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
Placebo TID (Panel C)Drug
Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
Placebo TID (Panel D)Drug
Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
Placebo TID (Panel E)Drug
Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.

Study groups in NCT01096160
Study group	Role	What they receive
Panel A: MK-8266 BID, 1 mg/Placebo	Experimental	MK-8266 1 mg (0.7 mg in the morning [AM] + 0.3 mg in the evening [PM]), or as matching placebo BID. Receives: Drug: MK-8226 BID, 1 mg; Drug: Placebo BID (Panel A)
Panel B: MK-8266 BID, 1.8 mg/Placebo	Experimental	MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. Receives: Drug: MK-8266 BID, 1.8 mg; Drug: Placebo BID (Panel B)
Panel C: MK-8266 TID, 1.8 mg/Placebo	Experimental	MK-8266 TID, 1.8 mg (0.6 mg every 6 hours [q6hr]), or as matching placebo TID. Receives: Drug: MK-8266 TID, 1.8 mg; Drug: Placebo TID (Panel C)
Panel D: MK-8266 TID, 2.4 mg/Placebo	Experimental	MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E. Receives: Drug: MK-8266 TID, 2.4 mg; Drug: Placebo TID (Panel D)
Panel E: MK-8266 TID, 2.4 mg/Placebo	Experimental	MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D. Receives: Drug: MK-8266 TID, 2.4 mg; Drug: Placebo TID (Panel E)

What is being measured

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

Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up
Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Measured: Up to 24 days
Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE
Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.
Measured: Up to 10 days
Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo
Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.
Measured: Baseline and Day 10
Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo
Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.
Measured: Day 10 (24 hours postdose)

Secondary outcomes (4)

Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo
Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.
Measured: Day 10
Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo
Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.
Measured: Baseline and Day 10
Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo
The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.
Measured: Baseline and Day 10 (5 hours postdose)
Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo
The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.
Measured: Baseline and Day 10 (5 hours postdose)

Timeline

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

1 Mar 20101 Nov 2010

First posted30 Mar 2010 (estimated)
Study start1 Mar 2010
Primary completion1 Nov 2010
Study completion1 Nov 2010

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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01096160
Sponsor's protocol ID: 8266-002
Other IDs: 2010-018654-13
Status last verified: Jun 2019
First submitted: 26 Mar 2010
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/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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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8266
ClinicalTrials.gov ID: NCT01096160
Acronym / sponsor ID: 8266-002
Conditions: Hypertension
Keywords: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Mar 2010 (actual)
Primary completion: 1 Nov 2010 (actual)
Study completion: 1 Nov 2010 (actual)
First posted: 30 Mar 2010 (estimated)
Results: Posted 12 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 evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Panel A: MK-8266 BID, 1 mg/Placebo	Experimental	Drug: MK-8226 BID, 1 mg, Drug: Placebo BID (Panel A)MK-8266 1 mg (0.7 mg in the morning [AM] + 0.3 mg in the evening [PM]), or as matching placebo BID.
Panel B: MK-8266 BID, 1.8 mg/Placebo	Experimental	Drug: MK-8266 BID, 1.8 mg, Drug: Placebo BID (Panel B)MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID.
Panel C: MK-8266 TID, 1.8 mg/Placebo	Experimental	Drug: MK-8266 TID, 1.8 mg, Drug: Placebo TID (Panel C)MK-8266 TID, 1.8 mg (0.6 mg every 6 hours [q6hr]), or as matching placebo TID.
Panel D: MK-8266 TID, 2.4 mg/Placebo	Experimental	Drug: MK-8266 TID, 2.4 mg, Drug: Placebo TID (Panel D)MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E.
Panel E: MK-8266 TID, 2.4 mg/Placebo	Experimental	Drug: MK-8266 TID, 2.4 mg, Drug: Placebo TID (Panel E)MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant is male with essential hypertension (high blood pressure)
Participant is in good general health (with the exception of hypertension)
Participant has a Body Mass Index (BMI) <= 33 kg/m^2 at the Screening visit
Participant has a platelet count >= 150,000 cu/mL at the Screening visit
Participant has a positive AIx at the Screening visit

Key exclusion criteria (6 listed)

Participant has a history of stroke, chronic seizure, or major neurological disease
Participant has a functional disability that can interfere with rising from a seated position to the standing position
Participant has any 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

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-8226 BID, 1 mgAlso: MK-8266MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.	Drug	Panel A: MK-8266 BID, 1 mg/Placebo
MK-8266 BID, 1.8 mgAlso: MK-8266MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.	Drug	Panel B: MK-8266 BID, 1.8 mg/Placebo
MK-8266 TID, 1.8 mgAlso: MK-8266MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.	Drug	Panel C: MK-8266 TID, 1.8 mg/Placebo
MK-8266 TID, 2.4 mgAlso: MK-8266MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.	Drug	Panel D: MK-8266 TID, 2.4 mg/Placebo
MK-8266 TID, 2.4 mgAlso: MK-8266MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.	Drug	Panel E: MK-8266 TID, 2.4 mg/Placebo
Placebo BID (Panel A)Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.	Drug	Panel A: MK-8266 BID, 1 mg/Placebo
Placebo BID (Panel B)Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.	Drug	Panel B: MK-8266 BID, 1.8 mg/Placebo
Placebo TID (Panel C)Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.	Drug	Panel C: MK-8266 TID, 1.8 mg/Placebo
Placebo TID (Panel D)Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.	Drug	Panel D: MK-8266 TID, 2.4 mg/Placebo
Placebo TID (Panel E)Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.	Drug	Panel E: MK-8266 TID, 2.4 mg/Placebo

Primary outcome

Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up
Time frame: Up to 24 days
Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE
Time frame: Up to 10 days
Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.
Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Baseline and Day 10
Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.
Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Day 10 (24 hours postdose)
Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.

4 secondary outcomes

Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Day 10
Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Baseline and Day 10
Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Baseline and Day 10 (5 hours postdose)
Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo
Time frame: Baseline and Day 10 (5 hours postdose)

Results and safety

Results posted to the registry on 12 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: MK-8266 BID (1 mg)	6	6
Panel A: Placebo BID	2	2
Panel B: MK-8266 BID (1.8 mg)	6	5
Panel B: Placebo BID	2	2
Panel C: MK-8266 TID (1.8 mg)	6	5
Panel C: Placebo TID	2	2
Panel D: MK-8266 TID (2.4 mg)	6	4
Panel D: Placebo TID	2	2
Panel E: MK-8266 TID (2.4 mg)	6	4
Panel E: Placebo TID	2	1

Primary outcome: Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up

Time frame: Up to 24 days. Number. Unit: Count of Participants

Measure	Panel A: MK-8266 BID (1 mg) n = 6	Panel A: Placebo n = 2	Panel B: MK-8266 BID (1.8 mg) n = 6	Panel B: Placebo n = 2	Panel C: MK-8266 TID (1.8 mg) n = 6	Panel C: Placebo n = 2	Panel D: MK-8266 TID (2.4 mg) n = 6	Panel D: Placebo n = 2	Panel E: MK-8266 TID (2.4 mg) n = 6	Panel E: Placebo n = 2
Value	5	0	5	1	3	1	4	1	5	2

Population analysed: All participants who received at least one dose of the investigational drug

Primary outcome: Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE

Time frame: Up to 10 days. Number. Unit: Count of Participants

Measure	Panel A: MK-8266 BID (1 mg) n = 6	Panel A: Placebo n = 2	Panel B: MK-8266 BID (1.8 mg) n = 6	Panel B: Placebo n = 2	Panel C: MK-8266 TID, 1.8 mg n = 6	Panel C: Placebo n = 2	Panel D: MK-8266 TID (2.4 mg) n = 6	Panel D: Placebo n = 2	Panel E: MK-8266 2.4 mg TID n = 6	Panel E: Placebo n = 2
Value	0	0	1	0	0	0	0	0	0	1

Population analysed: All participants who received at least one dose of the investigational drug

Primary outcome: Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo

Time frame: Baseline and Day 10. Least squares mean (Standard Deviation). Unit: Millimeters of mercury (mmHg)

Measure	Panel A: MK-8266 BID, 1 mg n = 6	Panel B: MK-8266 BID, 1.8 mg n = 5	Panel C: MK-8266 TID, 1.8 mg n = 5	Panels D & E Combined: MK-8266 TID, 2.4 mg n = 8	Pooled Placebo n = 9
Baseline value	141.5 (8.96)	132.6 (6.66)	148.6 (23.77)	134.5 (8.98)	146.7 (12.07)
Change from Baseline at Day 10	-5.09 (7.04)	-2.18 (6.80)	-4.78 (7.64)	0.77 (6.62)	-3.18 (7.72)

Panel A: MK-8266 BID, 1 mg vs Pooled Placebo: Mean Difference (Final Values): -7.08 (90% CI -17.1 to 2.92), p = 0.1194, Linear mixed effects model
Panel B: MK-8266 BID, 1.8 mg vs Pooled Placebo: Mean Difference (Final Values): -13.1 (90% CI -23.7 to -2.48), p = 0.0224, Linear mixed effects model
Panel C: MK-8266 TID, 1.8 mg vs Pooled Placebo: Mean Difference (Final Values): 0.33 (90% CI -10.3 to 10.91), p = 0.4791, Linear mixed effects model

Population analysed: All participants who received at least one dose of the investigational drug and had SBP assessments at Baseline and on Day 10

Primary outcome: Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo

Time frame: Day 10 (24 hours postdose). Mean (Standard Deviation). Unit: Beats per minute

Measure	Panel A: MK-8266 BID (1 mg) n = 6	Panel B: MK-8266 BID (1.8 mg) n = 5	Panel C: MK-8266 TID (1.8 mg) n = 5	Panels D & E Combined: MK-8266 TID: MK-8266 TID (2.4 mg) n = 8	Pooled Placebo n = 9
Value	65.89 (5.59)	69.32 (7.87)	62.30 (5.28)	66.10 (5.38)	62.04 (5.98)

Panel A: MK-8266 BID (1 mg) vs Pooled Placebo: Mean Difference (Final Values): 3.85 (90% CI -1.51 to 9.22), p = 0.1161, Linear mixed effects model
Panel B: MK-8266 BID (1.8 mg) vs Pooled Placebo: Mean Difference (Final Values): 7.28 (90% CI 1.60 to 12.97), p = 0.0189, Linear mixed effects model
Panel C: MK-8266 TID (1.8 mg) vs Pooled Placebo: Mean Difference (Final Values): 0.26 (90% CI -5.42 to 5.95), p = 0.4689, Linear mixed effects model

Population analysed: All participants who received at least one dose of the investigational drug and had HR assessments 24 hours postdose on Day 10.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A: MK-8266 BID, 1 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel A: Placebo BID	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Panel B: MK-8266 BID, 1.8 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel B: Placebo BID	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Panel C: MK-8266 TID, 1.8 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Panel C: Placebo TID	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Panel D: MK-8266 TID, 2.4 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Panel D: Placebo TID	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Panel E: MK-8266 TID, 2.4 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Panel E: Placebo TID	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8226 BID, 1 mg, MK-8266 BID, 1.8 mg and MK-8266 TID, 1.8 mg 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 5 inclusion and 6 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 12 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 12 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?

Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up (time frame: Up to 24 days). The study lists 4 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 NCT01096160.

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 12 Aug 2019.