A Study of Single Doses of Frespaciguat (MK-5475) on Pulm... | NCT03744637 | Trialant
NCT03744637
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jun 4, 2025Actual
Enrollment
25Actual
Phase
Phase 1
Conditions
Pulmonary Arterial Hypertension
Interventions
Frespaciguat
Placebo
Countries
Moldova
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03744637
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5475-002
Secondary IDs
ID
Type
Description
Link
MK-5475-002
Other Identifier
Merck Study Number
Brief Title
A Study of Single Doses of Frespaciguat (MK-5475) on Pulmonary Vascular Resistance (MK-5475-002)
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
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 18, 2019Actual
Primary Completion Date
Dec 11, 2020Actual
Completion Date
Dec 11, 2020Actual
First Submitted Date
Nov 13, 2018
First Submission Date that Met QC Criteria
Nov 13, 2018
First Posted Date
Nov 16, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 24, 2021
Results First Submitted that Met QC Criteria
Feb 22, 2022
Results First Posted Date
Feb 23, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 15, 2025
Last Update Posted Date
Jun 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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 Module
Conditions
Pulmonary Arterial Hypertension
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
25Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Panel A: Frespaciguat 120 ug/165 ug/240 ug/240 ug/240 ug (Parts 1 and 2)
Experimental
Participants in Panel A will receive a single inhaled dose of frespaciguat 120 ug in Period 1 of Part 1, followed by frespaciguat 165 ug in Period 2, followed by frespaciguat 240 ug in Period 3. Each dose will be separated by at least a 7-day washout. In Part 2 Period 2, participants will receive a single inhaled dose of frespaciguat 240 ug and undergo a right heart catheterization (RHC). In Part 2 Period 3, participants will receive a single inhaled dose of frespaciguat 240 ug and undergo a functional respiratory imaging (FRI).
Drug: Frespaciguat
Panel B: 300 ug/360 ug/360 ug (Part 2)
Experimental
Participants in Panel B will receive a single inhaled dose of frespaciguat 300 ug in Period 1 of Part 2. In Period 2 of Part 2, participants will receive a single inhaled dose of frespaciguat 360 ug and undergo FRI. In Period 3 of Part 2, participants receive a single inhaled dose of frespaciguat 360 ug and undergo RHC. Each dose will be separated by at least a 7-day washout.
Drug: Frespaciguat
Panel C: 300 ug/360 ug/360 ug (Part 2, Expansion)
Experimental
Participants in Panel C will receive a single inhaled dose of frespaciguat 300 ug in Period 1 of Part 2. In Period 2 of Part 2, participants will receive a single inhaled dose of frespaciguat 360 ug and undergo FRI. In Period 3 of Part 2, participants receive a single inhaled dose of frespaciguat 360 ug and undergo RHC. Each dose will be separated by at least a 7-day washout.
Drug: Frespaciguat
Panel D: 480 ug/120 ug/120 ug (Part 2)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Frespaciguat
Drug
Single inhaled dose of frespaciguat 120, 165, 240, 300, 360, or 480 ug depending upon randomization
Panel A: Frespaciguat 120 ug/165 ug/240 ug/240 ug/240 ug (Parts 1 and 2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced at Least 1 Adverse Event (AE): All Parts
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.
Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
Number of Participants Who Discontinued From the Study Due to an AE: All Parts
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.
Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
Percentage Change From Baseline in Minimum Pulmonary Vascular Resistance (PVR): Part 2 Right Heart Catheterization (RHC) 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.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and up to 4.5 hours post-dose
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Heart Rate (HR) at 0.5 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Be or have suspected Group 1 pulmonary hypertension as defined by the Nice 2013 Clinical Classification, including: idiopathic PAH, heritable PAH, drug- or toxin-induced PAH, or PAH associated with connective tissue disease or congenital heart disease
Have a Body Mass Index (BMI) ≤35 kg/m2,
Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: She is a woman of nonchildbearing potential (WONCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 14 days, corresponding to time needed to eliminate study intervention(s) after the last dose of study intervention: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (Vasectomized) or secondary to medical cause.
Have a clinical indication for right heart catheterization (RHC) as part of initial work-up or ongoing medical management
Panel A: Have history of RHC within 3 years of starting study medication demonstrating mean pulmonary artery pressure of ≥ 27 mmHg and pulmonary vascular resistance (PVR) of ≥ 300 dynes/sec/cm5
Panels B/C/D: Have history of RHC within 3 years of starting study medication demonstrating mean pulmonary artery pressure of ≥ 27 mmHg and PVR of ≥ 300 dynes/sec/cm5 OR have an echocardiogram performed by the investigator at screening or within 1 year of screening demonstrating pulmonary artery systolic pressure ≥ 50 mmHg in conjunction with 1 or more of the following: tricuspid regurgitation velocity > 3.0 m/s and or significant right heart enlargement and or reduced right heart function.
Exclusion Criteria:
Has pulmonary hypertension subtypes including the following according to Nice 2013 Clinical Classification: human immunodeficiency (HIV) infection, portal hypertension, schistosomiasis, chronic hemolytic anemia, pulmonary veno-occlusive disease (PVOD) and or pulmonary capillary hemangiomatosis (PCH), persistent pulmonary hypertension of the newborn (PPHN), pulmonary hypertension owing to left heart diseases, left ventricular systolic dysfunction, left ventricular diastolic dysfunction, valvular disease, congenital/acquired left heart inflow/outflow tract obstruction and congenital cardiomyopathies, pulmonary hypertension owing to lung diseases and/or hypoxia, Chronic obstructive pulmonary disease, Interstitial lung disease, other pulmonary diseases with mixed restrictive and obstructive pattern, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude, developmental abnormalities, pulmonary hypertension defined as chronic thromboembolic pulmonary hypertension [CTEPH]), pulmonary hypertension with unclear multifactorial mechanisms, hematologic disorders: chronic hemolytic anemia, myeloproliferative disorders, splenectomy, systemic disorders: sarcoidosis, pulmonary Langerhans cell histiocytosis, lymphangioleiomyomatosis, neurofibromatosis, vasculitis, metabolic disorders: glycogen storage disease, Gaucher disease, thyroid disorders, others: tumoral obstruction, fibrosing mediastinitis, chronic renal failure, segmental pulmonary hypertension
Has a history of clinically significant endocrine (not including stable diabetes mellitus), gastrointestinal, cardiovascular, hematological, hepatic (not including chronic stable Hepatitis B and Hepatitis C), immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Is mentally or legally incapacitated, has significant emotional problems
History of cancer (malignancy) except nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated 10 years prior to screening
History of significant multiple and/or severe allergies
Known hypersensitivity to iodine or iodine containing products
Positive for HIV
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks of screening
Has persistent or permanent atrial fibrillation with an uncontrolled ventricular rate
Has significantly impaired gas exchange
Has an active respiratory infection (e.g. common cold, bronchitis, influenza, pneumonia) with lung function outside of the normal range
Is currently on monotherapy calcium channel blockers as a specific treatment for pulmonary hypertension
Has taken nitrates within 24 hours of anticipated dosing
Has taken inhaled prostacyclin within 24 hours of anticipated dosing (iloprost or treprostinil)
Has taken diltiazem immediate release taken within 24 hours or extended release taken within 48 hours of anticipated dosing
Has taken sildenafil or vardenafil within 24 hours or tadalafil within 7 days of anticipated dosing
Has taken soluble guanylate cyclase (sGC) activator for PAH within 24 hours of anticipated dosing
Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit
Has participated in another investigational study within 4 weeks
Does not agree to follow the smoking restrictions
Part 2 only: Suffers from claustrophobia and would be unable to undergo computerized tomography (CT) scan
Part 2 only: Has participated in a positron-emission tomography (PET) research study or other study involving administration of a radioactive substance or ionizing radiation within 12 months prior to the screening visit, or has undergone or plans to have extensive radiological examination within this period
Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months. Participants must have a negative urine drug screen (UDS) prior to randomization
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Republican Clinical Hospital of Moldova ( Site 0001)
Adult participants with Group 1 Pulmonary Arterial Hypertension (PAH) were recruited to evaluate safety, pharmacokinetics (PK), Functional Respiratory Imaging (FRI), and Right Heart Catheterization (RHC) of single-dose MK-5475.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
FG001
MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
FG002
MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
FG003
Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).
FG004
Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A)
Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).
FG005
MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B)
Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).
Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
FG009
MK-5475 480 ug/ MK-5475 120 ug (Panel D)
Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0068 subjects
FG0074 subjects
FG0083 subjects
FG0091 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-5475 120 ug/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced at Least 1 Adverse Event (AE): All Parts
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.
All participants who received ≥1 dose of investigational treatment were analyzed according to treatment received.
Posted
Count of Participants
Participants
Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Adverse Events Module
Frequency Threshold
0
Time Frame
Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
Description
All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-5475 120 ug: Part 1 (Panel A)
Participants received MK-5475 120 ug during Part 1.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Part 1 of the study will evaluate safety, tolerability, and pharmacokinetics in this population using a sequential study design. Review of available safety data up to 24 hours post dose of at least the first 4 participants must occur prior to escalating to the next dose level. A break to review PK data from Periods 1 and 2 will occur after completion of Period 2. Review of safety will occur after completion of Period 3 in all participants from Panel A, prior to initiation of Part 2. An optional break to review rolling PK data from Panel A Period 3 will be dependent upon exposures observed in Periods 1 and 2.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
In Part 1 (Panel A) of this study, a double-blinding technique will be used. Frespaciguat and placebo will be packaged identically so that blind is maintained. The participant, the investigator, and Sponsor personnel or delegate(s) who are involved in the study intervention administration or clinical evaluation of the participants are unaware of the intervention assignments.
Part 2 of this study is conducted as open label; therefore, the Sponsor, investigator, and participant will know the intervention administered.
Who Masked
ParticipantInvestigator
Experimental
Participants in Panel D will receive a single inhaled dose of frespaciguat 480 ug in Period 1 of Part 2. In Period 2 of Part 2, participants will receive a single inhaled dose of frespaciguat 120 ug and undergo FRI. In Period 3 of Part 2, participants receive a single inhaled dose of frespaciguat 120 ug and undergo RHC. Each dose will be separated by at least a 7-day washout.
Drug: Frespaciguat
Placebo (Part 1)
Placebo Comparator
Participants will receive a single inhaled dose of matching placebo in Part 1.
Drug: Placebo
Panel B: 300 ug/360 ug/360 ug (Part 2)
Panel C: 300 ug/360 ug/360 ug (Part 2, Expansion)
Panel D: 480 ug/120 ug/120 ug (Part 2)
MK-5475
Placebo
Drug
Single inhaled dose of placebo to match frespaciguat
Placebo (Part 1)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
Change From Baseline in Heart Rate (HR) at 4.5 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
Change From Baseline in Heart Rate (HR) at 24 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
Change From Baseline in Systolic Blood Pressure (SBP) at 0.5 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
Change From Baseline in Systolic Blood Pressure (SBP) at 4.5 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
Change From Baseline in Systolic Blood Pressure (SBP) at 24 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
Change From Baseline in Diastolic Blood Pressure (DBP) at 0.5 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
Change From Baseline in Diastolic Blood Pressure (DBP) at 4.5 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
Change From Baseline in Diastolic Blood Pressure (DBP) at 24 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
Area Under the Concentration-Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the AUC0-inf of MK-5475. AUC0-inf was defined as the area under the concentration-time curve of MK-5475 from time zero to infinity. MK-5475 AUC0-inf was reported by panel/dose group. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for groups with n<2 participants.
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
Area Under the Concentration-Time Curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the AUC0-24hr of MK-5475. AUC0-24hr was defined as the area under the concentration-time curve of MK-5475 from time zero to 24 hours. MK-5475 AUC0-24hr was reported by panel/dose group. For RHC panel/dose groups where sampling was only done up to 4.5 hours, the AUC0-24hr geometric mean represents an extrapolated AUC0-24hr value. Per protocol, %GCV values were not reported for groups with n<2 participants.
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
Maximum Concentration (Cmax) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the Cmax of MK-5475. Cmax was defined as the maximum concentration of MK-5475 reached. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
Concentration of MK-5475 at 24 Hours Postdose (C24): All Parts
Blood samples were taken at predose and at specified time points postdose to determine the C24 of MK-5475. C24 was defined as the concentration of MK-5475 reached at 24 hours. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.
24 hours postdose
Time to Maximum Concentration (Tmax) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the Tmax of MK-5475. Tmax was defined as the time to maximum concentration of MK-5475. MK-5475 Tmax was reported by panel/dose group.
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
Apparent Terminal Half-life (t1/2) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the t½ of MK-5475. t½ was defined as the time required to divide the MK-5475 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-5475. MK-5475 t½ was reported by panel/dose group.
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period
Participants underwent a series of computed tomography (CT) scans with an intravenous (IV) iodinated contrast agent to facilitate assessment of PBV at baseline and at several times points after MK-5475 dosing. Percentage change from baseline (CFB) in PBV was calculated and reported for each dose group that underwent FRI in Part 2. As pre-specified, central tendency for PBV percentage CFB was provided as numerical values rounded to whole numbers. Per protocol, this outcome measure was only assessed during the Part 2 FRI Period for each panel and was not assessed during Part 1.
Baseline: Pre-dose on Day 1 of FRI Period (up to 227 days) and 1, 3, 8, and 24 hours post-dose
1 subjects
Participant did not receive MK-5475 240 ug in Part 2 as planned.
FG0051 subjectsParticipant received 165 ug in Part 2 Periods 2 and 3, instead of planned 360 ug.
FG0068 subjects
FG0074 subjectsParticipants received 120 ug in Part 2 Periods 2 and 3, instead of planned 360 ug.
FG0083 subjects
FG0091 subjectsParticipant did not receive 120 ug in Part 2 Period 3 as planned.
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
MK-5475 120 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), placebo (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
BG002
MK-5475 120 ug/MK-5475 165 ug/Placebo/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participants received inhaled doses as follows: MK-5475 120 ug (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), placebo (Part 1 Period 3), MK-5475 240 ug (Part 2 Period 2), and MK-5475 240 ug (Part 2 Period 3).
BG003
Placebo/MK-5475 165 ug/MK-5475 240 ug/MK-5475 240 ug/MK-5475 240 ug (Panel A)
Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), MK-5475 240 ug (Part 1 Period 3), 240 ug (Part 2 Period 2), and 240 ug (Part 2 Period 3).
BG004
Placebo/MK-5475 165 ug/MK-5475 240 ug (Panel A)
Participant received inhaled doses as follows: placebo (Part 1 Period 1), MK-5475 165 ug (Part 1 Period 2), and 240 ug (Part 1 Period 3).
BG005
MK-5475 300 ug/ MK-5475 165 ug/ MK-5475 165 ug (Panel B)
Participant received inhaled doses as follows: MK-5475 300 ug (Part 2 Period 1), MK-5475 165 ug (Part 2 Period 2), and 165 ug (Part 2 Period 3).
Participants received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1), MK-5475 120 ug (Part 2 Period 2), and 120 ug (Part 2 Period 3).
BG009
MK-5475 480 ug/ MK-5475 120 ug (Panel D)
Participant received inhaled doses as follows: MK-5475 480 ug (Part 2 Period 1) and MK-5475 120 ug (Part 2 Period 2).
BG010
Total
Total of all reporting groups
2
BG0012
BG0022
BG0031
BG0041
BG0051
BG0068
BG0074
BG0083
BG0091
BG01025
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.0± 1.4
BG00151.0± 4.2
BG00261.0± 4.2
BG00361.0± NANA = Standard Deviation not reported when n\<2.
BG00461.0± NANA = Standard Deviation not reported when n\<2.
BG00552.0± NANA = Standard Deviation not reported when n\<2.
BG00648.6± 14.4
BG00761.3± 2.2
BG00862.7± 5.9
BG00969.0± NANA = Standard Deviation not reported when n\<2.
BG01055.8± 10.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG0022
BG0030
BG0041
BG0050
BG0066
BG0073
BG0082
BG0091
BG01018
Male
BG0001
BG0010
BG0020
BG0031
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Not Hispanic or Latino
BG0002
BG0012
BG0022
BG0031
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0002
BG0012
BG0022
BG0031
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panels B+C)
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panels B+C)
Participants received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 120 ug: FRI (Panels C+D)
Participants received MK-5475 120 ug during the FRI Period.
OG011
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG012
MK-5475 240 ug: FRI (Panel A)
Participants received MK-5475 240 ug during the FRI Period.
OG013
MK-5475 360 ug: FRI (Panels B+C)
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG00313
OG0044
OG0056
OG0067
OG0071
OG0087
OG0098
OG0108
OG0111
OG0127
OG0138
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0023
OG0035
OG0042
OG0054
OG0065
OG0071
OG0086
OG0094
OG0101
OG0110
OG0120
OG0134
Primary
Number of Participants Who Discontinued From the Study Due to an AE: All Parts
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.
All participants who received ≥1 dose of investigational treatment were analyzed according to treatment received.
Posted
Count of Participants
Participants
Up to ~14 days after last dose of treatment period (Up to ~32 weeks total)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panels B+C)
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panels B+C)
Participants received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 120 ug: FRI (Panels C+D)
Participants received MK-5475 120 ug during the FRI Period.
OG011
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG012
MK-5475 240 ug: FRI (Panel A)
Participants received MK-5475 240 ug during the FRI Period.
OG013
MK-5475 360 ug: FRI (Panels B+C)
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percentage Change From Baseline in Minimum Pulmonary Vascular Resistance (PVR): Part 2 Right Heart Catheterization (RHC) 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.
All participants who received ≥1 dose of MK-5475, who complied with the protocol without major protocol deviations, and who underwent the RHC procedure and had available data were analyzed according to treatment received.
Posted
Mean
Standard Deviation
Percentage change
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and up to 4.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panels B+C)
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panels B+C)
Participants received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 120 ug: FRI (Panels C+D)
Participants received MK-5475 120 ug during the FRI Period.
OG011
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG012
MK-5475 240 ug: FRI (Panel A)
Participants received MK-5475 240 ug during the FRI Period.
OG013
MK-5475 360 ug: FRI (Panels B+C)
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG006-20.77± 13.88
OG00713.01± NANA = Standard Deviation not reported when n\<2.
OG008-29.46± 13.72
Secondary
Change From Baseline in Heart Rate (HR) at 0.5 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
beats/minute
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Heart Rate (HR) at 4.5 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
beats/minute
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Heart Rate (HR) at 24 Hours Post-dose: Part 2 RHC Period
HR was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline HR and change from baseline in HR was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in HR. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
beats/minute
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at 0.5 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at 4.5 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at 24 Hours Post-dose: Part 2 RHC Period
SBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline SBP and change from baseline in SBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in SBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at 0.5 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 0.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 0.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline DBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at 4.5 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 4.5 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 4.5 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline DBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at 24 Hours Post-dose: Part 2 RHC Period
DBP was assessed at pre-dose in the RHC Period (baseline) and at 24 hours post-dose. Baseline DBP and change from baseline in DBP was reported for each panel/dose group that underwent RHC in Part 2, according to treatment planned. Negative values indicate decreases from baseline in DBP. Per protocol, this outcome measure was only assessed during the Part 2 RHC Period for each panel and was not assessed during Part 1.
All participants who received ≥1 dose of MK-5475, underwent the RHC procedure, and had available data were analyzed. One Panel B participant received 165 ug instead of 360 ug but was included in the 360 ug RHC group. Four Panel C participants were dose-reduced from 360 to 120 ug but were included in the 360 ug RHC group.
Posted
Mean
Standard Error
Millimeters of mercury (mmHg)
Baseline: Pre-dose on Day 1 of RHC Period (up to 185 days) and 24 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participants received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG011
MK-5475 120 ug: FRI
Participants received MK-5475 120 ug during the FRI Period.
OG012
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG013
MK-5475 240 ug: FRI
Participants received MK-5475 240 ug during the FRI Period.
OG014
MK-5475 360 ug: FRI
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Baseline SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the AUC0-inf of MK-5475. AUC0-inf was defined as the area under the concentration-time curve of MK-5475 from time zero to infinity. MK-5475 AUC0-inf was reported by panel/dose group. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for groups with n<2 participants.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for AUC0-inf were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM*hr
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0002
OG0015
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.00± 45.5
OG0010.721± 103.6
OG0021.25± 59.7
OG003
Secondary
Area Under the Concentration-Time Curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the AUC0-24hr of MK-5475. AUC0-24hr was defined as the area under the concentration-time curve of MK-5475 from time zero to 24 hours. MK-5475 AUC0-24hr was reported by panel/dose group. For RHC panel/dose groups where sampling was only done up to 4.5 hours, the AUC0-24hr geometric mean represents an extrapolated AUC0-24hr value. Per protocol, %GCV values were not reported for groups with n<2 participants.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for AUC0-24hr were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM*hr
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.259± 288.2
OG0010.613± 136.0
OG0021.42± 59.9
OG003
Secondary
Maximum Concentration (Cmax) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the Cmax of MK-5475. Cmax was defined as the maximum concentration of MK-5475 reached. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for Cmax were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0722± 153.3
OG0010.139± 117.9
OG0020.297± 60.8
OG003
Secondary
Concentration of MK-5475 at 24 Hours Postdose (C24): All Parts
Blood samples were taken at predose and at specified time points postdose to determine the C24 of MK-5475. C24 was defined as the concentration of MK-5475 reached at 24 hours. MK-5475 Cmax was reported by panel/dose group. Per protocol, %GCV values were not reported for groups with n<2 participants.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for C24 were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
24 hours postdose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA= no participant had detectable C24
OG001NA± NANA= no participant had detectable C24
OG002NA± NANA= no participant had detectable C24
Secondary
Time to Maximum Concentration (Tmax) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the Tmax of MK-5475. Tmax was defined as the time to maximum concentration of MK-5475. MK-5475 Tmax was reported by panel/dose group.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for Tmax were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Median
Full Range
Hour
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.00 to 2.00)
OG0011.00(1.00 to 2.00)
OG0022.00(1.00 to 2.00)
OG003
Secondary
Apparent Terminal Half-life (t1/2) of MK-5475: All Parts
Blood samples were taken at predose and at specified time points postdose to determine the t½ of MK-5475. t½ was defined as the time required to divide the MK-5475 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-5475. MK-5475 t½ was reported by panel/dose group.
All participants who received at least one dose of MK-5475, who complied with the protocol without major protocol deviations, and who had available data for t½ were analyzed. Per protocol, data from participants receiving placebo were not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Part 1 and Part 2 Period 1: Predose and 0.1, 0.25, 0.5, 1, 2, 3, 4, 8, and 24 hours post-dose; RHC Period: predose and 0.25, 0.5, 1, 2, 3, 4, and 4.5 hours; FRI Period: predose and 1, 3, 8, and 24 hours postdose (Panel D also 0.25, 0.5, 2, 4 hours)
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants in Panel A received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panel B)
Participants in Panel B received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 300 ug: Part 2 Period 1 (Panel C)
Participants in Panel C received MK-5475 300 ug during Part 2 Period 1.
OG005
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants in Panel D received MK-5475 480 ug during Part 2 Period 1.
OG006
Placebo: Part 1
Participants received placebo during Part 1.
OG007
MK-5475 120 ug: RHC (Panel C)
Participants in Panel C received MK-5475 120 ug during the RHC Period.
OG008
MK-5475 120 ug: RHC (Panel D)
Participants in Panel D received MK-5475 120 ug during the RHC Period.
OG009
MK-5475 165 ug: RHC (Panel B)
Participant in Panel B received MK-5475 165 ug during the RHC Period.
OG010
MK-5475 240 ug: RHC (Panel A)
Participants in Panel A received MK-5475 240 ug during the RHC Period.
OG011
MK-5475 360 ug: RHC (Panel B)
Participants in Panel B received MK-5475 360 ug during the RHC Period.
OG012
MK-5475 360 ug: RHC (Panel C)
Participants in Panel C received MK-5475 360 ug during the RHC Period.
OG013
MK-5475 120 ug: FRI (Panel C)
Participants in Panel C received MK-5475 120 ug during the FRI Period.
OG014
MK-5475 120 ug: FRI (Panel D)
Participants in Panel D received MK-5475 120 ug during the FRI Period.
OG015
MK-5475 165 ug: FRI (Panel B)
Participant in Panel B received MK-5475 165 ug during the FRI Period.
OG016
MK-5475 240 ug: FRI (Panel A)
Participants in Panel A received MK-5475 240 ug during the FRI Period.
OG017
MK-5475 360 ug: FRI (Panel B)
Participants in Panel B received MK-5475 360 ug during the FRI Period.
OG018
MK-5475 360 ug: FRI (Panel C)
Participants in Panel C received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0002
OG0015
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.73± 11.4
OG0011.76± 10.9
OG0021.87± 13.5
OG003
Secondary
Percentage Change From Baseline in Pulmonary Blood Volume (PBV) Over Time: Part 2 Functional Respiratory Imaging (FRI) Period
Participants underwent a series of computed tomography (CT) scans with an intravenous (IV) iodinated contrast agent to facilitate assessment of PBV at baseline and at several times points after MK-5475 dosing. Percentage change from baseline (CFB) in PBV was calculated and reported for each dose group that underwent FRI in Part 2. As pre-specified, central tendency for PBV percentage CFB was provided as numerical values rounded to whole numbers. Per protocol, this outcome measure was only assessed during the Part 2 FRI Period for each panel and was not assessed during Part 1.
All participants who received MK-5475 at 120, 240 or 360 ug during the FRI period and underwent CT scans with IV contrast agent at all time points were included in the analysis.
Posted
Number
Percentage change
Baseline: Pre-dose on Day 1 of FRI Period (up to 227 days) and 1, 3, 8, and 24 hours post-dose
ID
Title
Description
OG000
MK-5475 120 ug: Part 1 (Panel A)
Participants received MK-5475 120 ug during Part 1.
OG001
MK-5475 165 ug: Part 1 (Panel A)
Participants received MK-5475 165 ug during Part 1.
OG002
MK-5475 240 ug: Part 1 (Panel A)
Participants received MK-5475 240 ug during Part 1.
OG003
MK-5475 300 ug: Part 2 Period 1 (Panels B+C)
Participants received MK-5475 300 ug during Part 2 Period 1.
OG004
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants received MK-5475 480 ug during Part 2 Period 1.
OG005
Placebo: Part 1
Participants received placebo during Part 1.
OG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
OG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
OG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
OG009
MK-5475 360 ug: RHC (Panels B+C)
Participants received MK-5475 360 ug during the RHC Period.
OG010
MK-5475 120 ug: FRI (Panels C+D)
Participants received MK-5475 120 ug during the FRI Period.
OG011
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
OG012
MK-5475 240 ug: FRI (Panel A)
Participants received MK-5475 240 ug during the FRI Period.
OG013
MK-5475 360 ug: FRI (Panels B+C)
Participants received MK-5475 360 ug during the FRI Period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
CFB at 1 hour
Title
Measurements
OG010-2
OG0122
OG0133
CFB at 3 hours
0
6
0
6
2
6
EG001
MK-5475 165 ug: Part 1 (Panel A)
Participants received MK-5475 165 ug during Part 1.
0
6
0
6
1
6
EG002
MK-5475 240 ug: Part 1 (Panel A)
Participants received MK-5475 240 ug during Part 1.
0
6
0
6
3
6
EG003
MK-5475 300 ug: Part 2 Period 1 (Panels B+C)
Participants received MK-5475 300 ug during Part 2 Period 1.
0
13
0
13
5
13
EG004
MK-5475 480 ug: Part 2 Period 1 (Panel D)
Participants received MK-5475 480 ug during Part 2 Period 1.
0
4
0
4
2
4
EG005
Placebo: Part 1
Participants received placebo during Part 1.
0
6
0
6
4
6
EG006
MK-5475 120 ug: RHC (Panel D)
Participants received MK-5475 120 ug during the RHC Period.
0
7
0
7
5
7
EG007
MK-5475 165 ug: RHC (Panel B)
Participant received MK-5475 165 ug during the RHC Period.
0
1
0
1
1
1
EG008
MK-5475 240 ug: RHC (Panel A)
Participants received MK-5475 240 ug during the RHC Period.
0
7
0
7
6
7
EG009
MK-5475 360 ug: RHC (Panels B+C)
Participants received MK-5475 360 ug during the RHC Period.
0
8
0
8
4
8
EG010
MK-5475 120 ug: FRI (Panels C+D)
Participants received MK-5475 120 ug during the FRI Period.
0
8
0
8
1
8
EG011
MK-5475 165 ug: FRI (Panel B)
Participant received MK-5475 165 ug during the FRI Period.
0
1
0
1
0
1
EG012
MK-5475 240 ug: FRI (Panel A)
Participants received MK-5475 240 ug during the FRI Period.
0
7
0
7
0
7
EG013
MK-5475 360 ug: FRI (Panels B+C)
Participants received MK-5475 360 ug during the FRI Period.
0
8
0
8
4
8
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected8 at risk
Flatulence
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Contrast media allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Chronic sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected4 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected8 at risk
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Blood pressure increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected8 at risk
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected7 at risk
EG0071 events1 affected1 at risk
EG0084 events4 affected7 at risk
EG0093 events3 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Haemangioma of bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Benign enlargement of the subarachnoid spaces
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0101 events1 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected8 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected8 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
0
BG0051
BG0062
BG0071
BG0081
BG0090
BG0107
1
BG0051
BG0068
BG0074
BG0083
BG0091
BG01025
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
1
BG0051
BG0068
BG0074
BG0083
BG0091
BG01025
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
13
OG0044
OG0056
OG0067
OG0071
OG0087
OG0098
OG0108
OG0111
OG0127
OG0138
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
0
OG0040
OG0050
OG0067
OG0071
OG0087
OG0098
OG0100
OG0110
OG0120
OG0130
OG009
-29.25
± 17.58
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00674.75± 9.78
OG00862.57± 6.23
OG00968.75± 2.36
OG01069.06± 4.29
Change from Baseline in HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0086
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG0063.56± 7.60
OG0081.83± 1.56
OG0094.92± 3.03
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00674.75± 9.78
OG00862.57± 6.23
OG00968.75± 2.36
OG01069.06± 4.29
Change from Baseline in HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006-0.56± 4.55
OG0083.20± 3.51
OG0097.17± 1.55
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00674.75± 9.78
OG00862.57± 6.23
OG00968.75± 2.36
OG01069.06± 4.29
Change from Baseline in HR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG0061.78± 7.35
OG0087.43± 3.32
OG0092.42± 3.10
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006123.25± 9.80
OG008132.86± 3.79
OG009128.50± 9.65
OG010119.11± 4.72
Change from Baseline in SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0086
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00625.33± 2.52
OG0082.67± 3.70
OG009-1.17± 3.46
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006123.25± 9.80
OG008132.86± 3.79
OG009128.50± 9.65
OG010119.11± 4.72
Change from Baseline in SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00610.67± 0.38
OG0084.93± 5.65
OG0097.50± 1.55
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006123.25± 9.80
OG008132.86± 3.79
OG009128.50± 9.65
OG010119.11± 4.72
Change from Baseline in SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG0066.22± 5.28
OG008-5.95± 5.78
OG0092.25± 7.62
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00669.75± 4.03
OG00872.43± 2.25
OG00977.00± 4.95
OG01070.78± 3.52
Change from Baseline in DBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0086
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG0064.00± 4.60
OG0080.94± 1.68
OG0090.75± 3.48
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00669.75± 4.03
OG00872.43± 2.25
OG00977.00± 4.95
OG01070.78± 3.52
Change from Baseline in DBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006-0.22± 4.87
OG0081.07± 2.34
OG0093.58± 2.73
OG010
0
OG0040
OG0050
OG0064
OG0070
OG0087
OG0094
OG0109
OG0110
OG0120
OG0130
OG0140
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG00669.75± 4.03
OG00872.43± 2.25
OG00977.00± 4.95
OG01070.78± 3.52
Change from Baseline in SBP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0087
ParticipantsOG0094
ParticipantsOG0109
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG006-1.44± 0.89
OG008-2.76± 3.22
OG0092.42± 3.15
OG010
4
OG0049
OG0054
OG0060
OG0074
OG0083
OG0090
OG0106
OG0113
OG0125
OG0133
OG0144
OG0151
OG0160
OG0170
OG0184
2.15
± 106.3
OG0041.66± 66.8
OG0054.59± 20.9
OG0071.03± 20.0
OG0081.05± 28.9
OG0101.03± 59.7
OG0111.46± 63.2
OG0123.46± 67.3
OG0130.748± 43.9
OG0140.978± 18.3
OG0154.26± NANA = %GCV values were not reported when n\<2
OG0184.10± 37.6
4
OG0049
OG0054
OG0060
OG0074
OG0084
OG0091
OG0107
OG0113
OG0125
OG0134
OG0144
OG0151
OG0167
OG0173
OG0185
2.35
± 96.2
OG0041.82± 63.2
OG0054.53± 21.0
OG0071.02± 18.5
OG0081.05± 28.9
OG009NA± NANA = Not calculated due to insufficient samples on the terminal phase to estimate lambda z
OG0101.04± 59.0
OG0111.45± 61.7
OG0123.48± 68.3
OG0130.747± 43.5
OG0141.13± 18.4
OG0154.19± NANA = %GCV values were not reported when n\<2
OG0161.71± 43.3
OG0171.21± 80.1
OG0183.82± 35.3
4
OG0049
OG0054
OG0060
OG0074
OG0084
OG0091
OG0107
OG0113
OG0125
OG0134
OG0144
OG0151
OG0167
OG0173
OG0185
0.543
± 73.9
OG0040.409± 66.0
OG0050.981± 22.9
OG0070.218± 4.7
OG0080.161± 76.5
OG0090.312± NANA = %GCV values were not reported when n\<2
OG0100.202± 59.7
OG0110.307± 21.7
OG0120.960± 67.9
OG0130.228± 36.8
OG0140.245± 21.7
OG0150.601± NANA = %GCV values were not reported when n\<2
OG0160.341± 40.1
OG0170.301± 69.8
OG0180.915± 56.5
4
OG0049
OG0054
OG0060
OG0074
OG0084
OG0091
OG0107
OG0113
OG0125
OG0134
OG0144
OG0151
OG0167
OG0173
OG0185
OG003NA± NANA= no participant had detectable C24
OG004NA± NANA= no participant had detectable C24
OG0050.0113± 25.0
OG007NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG008NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG009NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG010NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG011NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG012NA± NANA = C24 could not be calculated since PK samples were only collected up to 4.5 hours in the RHC Period
OG013NA± NANA= no participant had detectable C24
OG014NA± NANA= no participant had detectable C24
OG0150.0128± NANA = %GCV values were not reported when n\<2
OG016NA± NANA = C24 could not be calculated due to an insufficient number of participants with detectable C24 to calculate geometric mean (%GCV)
OG017NA± NANA= no participant had detectable C24
OG018NA± NANA = C24 could not be calculated due to an insufficient number of participants with detectable C24 to calculate geometric mean (%GCV)
4
OG0049
OG0054
OG0060
OG0074
OG0084
OG0091
OG0107
OG0113
OG0125
OG0134
OG0144
OG0151
OG0167
OG0173
OG0185
1.50
(1.00 to 2.00)
OG0041.00(1.00 to 2.00)
OG0051.00(1.00 to 2.00)
OG0071.00(0.50 to 1.00)
OG0081.00(0.00 to 1.00)
OG0093.00(3.00 to 3.00)
OG0102.00(1.00 to 3.00)
OG0111.00(1.00 to 1.00)
OG0121.00(0.50 to 1.00)
OG0131.00(1.00 to 3.00)
OG0141.50(1.00 to 2.00)
OG0151.00(1.00 to 1.00)
OG0161.00(1.00 to 3.00)
OG0171.00(1.00 to 3.00)
OG0181.00(1.00 to 1.00)
4
OG0049
OG0054
OG0060
OG0074
OG0083
OG0090
OG0106
OG0113
OG0125
OG0133
OG0144
OG0151
OG0160
OG0170
OG0184
2.12
± 37.2
OG0042.18± 37.9
OG0053.67± 6.6
OG0072.82± 10.5
OG0082.32± 21.0
OG0102.35± 9.2
OG0113.13± 45.5
OG0122.05± 11.6
OG0132.45± 24.6
OG0142.19± 8.1
OG0153.89± NANA = %GCV values were not reported when n\<2