Trial Outcomes & Findings for A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED) (NCT NCT00679055)

Last Updated: 2018-08-17

Results Overview

CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	MK-0736 Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo Participants will be orally administered placebo once daily for 12 weeks.
Overall Study STARTED	8	6
Overall Study COMPLETED	6	1
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-0736 Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo Participants will be orally administered placebo once daily for 12 weeks.
Overall Study Adverse Event	0	1
Overall Study Other	0	3
Overall Study Study Terminated	2	1

Baseline Characteristics

A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0736 n=8 Participants Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo n=6 Participants Participants will be orally administered placebo once daily for 12 weeks.	Total n=14 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 7.4 • n=5 Participants	70.8 years STANDARD_DEVIATION 8.6 • n=7 Participants	69.0 years STANDARD_DEVIATION 7.82 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Study terminated early. Planned analyses was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Study terminated early. Planned analyses was not performed.

mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 14 weeks

Population: All enrolled participants who received at least one dose of study drug.

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 study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.

Outcome measures

Outcome measures
Measure	MK-0736 n=8 Participants Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo n=6 Participants Participants will be orally administered placebo once daily for 12 weeks.
Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)	0 Particpants	1 Particpants

Adverse Events

MK-0736

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-0736 n=8 participants at risk Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo n=6 participants at risk Participants will be orally administered placebo once daily for 12 weeks.
Cardiac disorders Cardiac failure acute	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
General disorders Chest pain	12.5% 1/8 • Number of events 2 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-0736 n=8 participants at risk Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks	Placebo n=6 participants at risk Participants will be orally administered placebo once daily for 12 weeks.
Cardiac disorders Angina pectoris	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Cardiac disorders Tachyarrhythmia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Gastrointestinal disorders Ileus paralytic	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
General disorders Pain	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
General disorders Swelling	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Hepatobiliary disorders Hepatic congestion	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Infections and infestations Infectious mononucleosis	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Infections and infestations Sinusitis	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Injury, poisoning and procedural complications Accidental overdose	25.0% 2/8 • Number of events 2 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	33.3% 2/6 • Number of events 2 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 2 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 2 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Nervous system disorders Tremor	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	0.00% 0/6 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	12.5% 1/8 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.	16.7% 1/6 • Number of events 1 • up to 14 weeks All enrolled participants who recieved at least one dose of study drug.