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Monoclonal Antibodies

MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose

Summary

This trial is testing a new drug, MK-3475, for safety and effectiveness in reducing pulmonary vascular resistance (PVR) in people with PH-COPD. The hypothesis is that MK-3475 will be better than placebo at reducing PVR.

Eligible Conditions

Pulmonary Hypertension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage Change From Baseline to Day 28 in Pulmonary Vascular Resistance (PVR): Part 2

Percentage of Participants Who Discontinued Study Drug Due to an AE

Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)

Secondary study objectives

AUC0-24 Accumulation Ratio of MK-5475: Part 1

AUC0-24 of MK-5475: Part 2

AUC0-3 Accumulation Ratio of MK-5475: Part 2

+15 more

Side effects data

From 2022 Phase 1 trial • 22 Patients • NCT04370873

33%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo (Part 2)

MK-5475 360 µg (Part 1)

Placebo (Part 1)

MK-5475 380 µg (Part 2)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: MK-5475Experimental Treatment1 Intervention

Participants receive MK-5475 32 µg, 100 µg, 195 µg or 380 μg QD via inhalation from Days 1-28.

Group II: Part 1: MK-5475Experimental Treatment1 Intervention

Participants receive MK-5475 360 μg once daily (QD) via inhalation from Days 1-7. Following review of pharmacokinetic (PK) and safety data, a second 7 days of dosing may be initiated. A dose of up to 360 μg up to twice a day may be administered based on PK data in these participants.

Group III: Part 1: PlaceboPlacebo Group1 Intervention

Participants receive placebo QD via inhalation from Days 1-7.

Group IV: Part 2: PlaceboPlacebo Group1 Intervention

Participants receive placebo QD via inhalation from Days 1-28.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-5475

2019

Completed Phase 3

~220