NCT04370873

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

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Pulmonary Hypertension Associated With COPD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess the safety/tolerability and efficacy (by evaluating changes in pulmonary vascular resistance \[PVR\] and pulmonary blood volume \[PBV\]) of frespaciguat in participants with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The primary hypothesis is that 28 days of frespaciguat treatment is superior to placebo treatment in reduction of PVR.

Detailed description

Part 1 of this study will assess safety, tolerability, and PK of frespaciguat compared to placebo. Part 2 will assess safety, tolerability, PK, and changes in PVR and PBV of frespaciguat compared to placebo.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Frespaciguat	Frespaciguat 32 µg, 100 µg, 195 µg, 360 µg or 380 µg administered as dry powder inhalation according to randomization. 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. Dosage may be adjusted downwards in Part 2, if indicated by PK results in Part 1.
DRUG	Placebo	Placebo administered as dry powder inhalation according to randomization

Timeline

• Start date: 2020-06-05
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2020-05-01
• Last updated: 2025-05-28
• Results posted: 2024-04-26

Locations

9 sites across 3 countries: United States, Israel, Moldova

Regulatory

• FDA-regulated drug study