Frespaciguat

PVR was calculated in participants after MK-5475 dosing at baseline and Week 12. PVR is assessed by right heart catheterization (RHC). Based on the variables obtained by right heart catheterization (RHC), the percentage change from baseline PVR was calculated. Per protocol, this outcome measure was assessed only for base period and was not assessed during extension period.

6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses functional capacity. It measures the distance covered over a time of 6 minutes and is intended to be used as an outcome measure by which to compare changes in excercise capacity. Each participant's 6MWD is to be measured at baseline and at 12 weeks. An increase in the distance walked during the 6MWT indicates improvement in functional exercise capacity.

6MWD is assessed using the 6-minute walk test (6MWT).

Amount of \[14C\]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.

Cumulative amount of \[14C\] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval

Percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.

Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.

Amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

Cumulative amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475.

AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475.

Cmax is the measure of the maximum amount of \[14C\]MK-5475 in the plasma after the dose is given.

T1/2 is the time required for \[14C\]MK-5475 concentration in the plasma to decrease by 50%.

Tmax is a measure of the time to reach the maximum concentration in the plasma after the \[14C\]MK-5475 dose.

CL is defined as apparent total clearance of \[14C\]MK-5475 from plasma after IV administration

Vz is defined as apparent volume of distribution of \[14C\]MK-5475 during terminal phase after IV administration.

AUC time zero to infinity (0-∞) of \[14C\]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE was assessed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.

PVR was calculated in participants after MK-5475 dosing at baseline and Day 28. Based on the variables obtained by right heart catheterization (RHC), the fold change from baseline individual PVR was calculated. The difference from baseline was assessed on the log scale and then back-transformed for reporting (percent change from baseline). Per protocol, this outcome measure was only assessed during the Part 2 and was not assessed during part 1.

An AE was defined as any untoward medical occurrence in a participant which may not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that was temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The number of participants who experienced at least 1 AE was reported by dose separately for Part 1 plus Part 2 Period 1, for the RHC Period, and for the FRI Period.

An AE was defined as any untoward medical occurrence in a participant which may not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that was temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The number of participants who discontinued from the study due to an AE was reported by dose separately for Part 1 plus Part 2 Period 1, for the RHC Period, and for the FRI Period.

For each participant in the RHC Period, the percentage change from baseline for the minimum post-dose PVR value over the duration of the RHC procedure was calculated. The average of pre-dose measurements was set as the baseline. Mean (SD) percent change from baseline in PVR minimum were calculated and reported for each dose group that underwent RHC in Part 2. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.