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

Pulmonary Arterial Hypertension Clinical Trial

Official title:
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

Clinical Trial Summary

This study of MK-5475 in participants with Group 1 pulmonary arterial hypertension (PAH) will assess the safety, tolerability and pharmacokinetics (PK) of inhaled MK-5475. There is no formal hypothesis to be tested.

Clinical Trial 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 MK-5475 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 MK-5475. 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03744637
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 1
Start date January 18, 2019
Completion date December 11, 2020
View Details
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