Trial Outcomes & Findings for A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease (MK-8892-007) (NCT NCT02078557)

Results Overview

Pulmonary vascular resistance (PVR) is the general pressure which the right ventricle must counteract to pump blood through the lungs. PVR was measured by right heart catheterization performed prior to dosing at baseline (Day 1) and 4 hours postdose on Day 28. Percentage change in PVR from baseline at Day 28 was calculated as \[(Baseline-Day 28)/Baseline\]. Standard deviation is reported as a percentage.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2018-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	MK-8892 MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease (MK-8892-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8892 n=4 Participants MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
Age, Continuous	60 Years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: The population for the efficacy analysis consisted of all participants who completed the 28 days of study.

Pulmonary vascular resistance (PVR) is the general pressure which the right ventricle must counteract to pump blood through the lungs. PVR was measured by right heart catheterization performed prior to dosing at baseline (Day 1) and 4 hours postdose on Day 28. Percentage change in PVR from baseline at Day 28 was calculated as \[(Baseline-Day 28)/Baseline\]. Standard deviation is reported as a percentage.

Outcome measures

Outcome measures
Measure	MK-8892 n=4 Participants MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
Percentage Change From Baseline in Pulmonary Vascular Resistance (PVR)	-51 Percentage change Standard Deviation 199

PRIMARY outcome

Timeframe: Up to 42 days

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

An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.

Outcome measures

Outcome measures
Measure	MK-8892 n=4 Participants MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
Number of Participants Who Experienced an Adverse Event	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days

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

An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.

Outcome measures

Outcome measures
Measure	MK-8892 n=4 Participants MK-8892 once daily for 28 days titrated to the highest tolerated dose per participant (up to 4 mg).
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0 Participants

Adverse Events

MK-8892

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER