NCT03744637

A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002)

A Study to Assess the Effect of Single Doses of MK-5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study of frespaciguat in participants with Group 1 pulmonary arterial hypertension (PAH) will assess the safety, tolerability and pharmacokinetics (PK) of inhaled frespaciguat. There is no formal hypothesis to be tested.

Detailed description

In Part 1, one panel (Panel A) of up to 8 participants will dose in up to 3 dosing periods, with a minimum washout of 7 days between dosing periods. In each dosing period, 6 participants will receive frespaciguat and 2 will receive placebo, with 2 different participants receiving placebo in each of the dosing periods. Review of available safety data will occur prior to escalating to the next dose level. Participants from Part 1 may continue into Part 2, which will assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single-dose inhaled frespaciguat. Three additional panels of participants (Panels B, C and D) will be enrolled into Part 2. Participants in Panel A will participate in 2 open-label dosing periods to assess PD measures associated with right heart catherization (RHC) \[Period 2\] and functional respiratory imaging (FRI) \[Period 3\]. Participants in Panels B, C, and D will participate in 3 dosing periods: Period 1 (open-label assessment of safety/tolerability and PK), Period 2 (FRI period) and Period 3 (RHC period).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Frespaciguat	Single inhaled dose of frespaciguat 120, 165, 240, 300, 360, or 480 ug depending upon randomization
DRUG	Placebo	Single inhaled dose of placebo to match frespaciguat

Timeline

• Start date: 2019-01-18
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2018-11-16
• Last updated: 2025-06-04
• Results posted: 2022-02-23

Locations

1 site across 1 country: Moldova