Phase
Condition
Pulmonary Arterial Hypertension
Stress
Williams Syndrome
Treatment
PF-07868489
Placebo for PF-07868489
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria Part A:
overtly healthy
Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg.
Key Exclusion Criteria Part A:
clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.
Key Inclusion Criteria Part B:
diagnosis of pulmonary arterial hypertension (PAH)
stable dose of standard of care PAH vasodilators
BMI 16 to 40 kg/m2; and a total body weight >45 kg.
6MWD ≥ 150 and ≤ 450.
Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.
Key Exclusion Criteria Part B:
Any medical or psychiatric condition or laboratory abnormality.
Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
Pulmonary capillary wedge pressure > 15 mmHg on right heart catheterization (RHC) conducted during Screening.
History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
Major surgery within 8 weeks prior to randomization.
Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.
Study Design
Connect with a study center
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland 4066
AustraliaSite Not Available
Wesley Research Institute
Auchenflower, Queensland 4066
AustraliaSite Not Available
Wesley Research Institute
Auchenflower 6943571, Queensland 2152274 4066
AustraliaSite Not Available
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région DE 1070
BelgiumSite Not Available
Université Libre de Bruxelles - Hôpital Erasme
Brussels 2800866, Bruxelles-capitale, Région de 1070
BelgiumSite Not Available
UZ Leuven
Leuven, Vlaams-brabant 3000
BelgiumSite Not Available
UZ Leuven
Leuven 2792482, Vlaams-brabant 3000
BelgiumSite Not Available
London Health Sciences Centre - University Hospital
London, Ontario N6G 2M3
CanadaSite Not Available
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario N6A 5W9
CanadaSite Not Available
London Health Sciences Centre - University Hospital
London 6058560, Ontario 6093943 N6G 2M3
CanadaSite Not Available
London Health Sciences Centre - Verspeeten Family Cancer Centre
London 6058560, Ontario 6093943 N6A 5W9
CanadaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691 410011
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing 1799962, Jiangsu 1806260 210009
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality 200433
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200433
ChinaSite Not Available
Institut Klinicke a Experimentalni Mediciny
Prague, 140 21
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Prague, 12808
CzechiaSite Not Available
Institut Klinicke a Experimentalni Mediciny
Prague 3067696, 140 21
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Prague 3067696, 12808
CzechiaSite Not Available
CHRU de Brest
Brest, Finistère 29200
FranceSite Not Available
CHRU de Brest
Brest 3030300, Finistère 29200
FranceSite Not Available
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region 42270
FranceSite Not Available
Chu Grenoble Alpes
La Tronche, 38700
FranceSite Not Available
Chu Grenoble Alpes
La Tronche 3006131, 38700
FranceSite Not Available
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg 69126
GermanySite Not Available
Thoraxklinik-Heidelberg gGmbH
Heidelberg 2907911, Baden-Wurttemberg 2953481 69126
GermanySite Not Available
Universitätsklinikum Regensburg
Regensburg, Bavaria 93053
GermanySite Not Available
Universitätsklinikum Regensburg
Regensburg 2849483, Bavaria 2951839 93053
GermanySite Not Available
UKGM Gießen/Marburg
Giessen, Hesse 35392
GermanySite Not Available
UKGM Gießen/Marburg
Giessen 2920512, Hesse 2905330 35392
GermanySite Not Available
UKGM Gießen/Marburg
Gießen, Hessen 35392
GermanySite Not Available
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern 17475
GermanySite Not Available
Universitätsmedizin Greifswald
Greifswald 2917788, Mecklenburg-Vorpommern 2872567 17475
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony 01307
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden 2935022, Saxony 2842566 01307
GermanySite Not Available
Onassis Hospital
Kallithea, Attica 17674
GreeceSite Not Available
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí 12462
GreeceSite Not Available
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári 260183, Attikí 12462
GreeceSite Not Available
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Central Macedonia 54636
GreeceSite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza 20900
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza 3172629, Monza E Brianza 20900
ItalySite Not Available
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, 90127
ItalySite Not Available
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo 2523920, 90127
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia 3171366, 27100
ItalySite Not Available
Kobe University Hospital
Kobe, Hyōgo 650-0017
JapanSite Not Available
Kobe University Hospital
Kobe 1859171, Hyōgo 1862047 650-0017
JapanSite Not Available
St. Marianna University Hospital
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
St. Marianna University Hospital
Kawasaki 1859642, Kanagawa 1860291 216-8511
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanSite Not Available
Tohoku University Hospital
Sendai 2111149, Miyagi 2111888 980-8574
JapanSite Not Available
Yokohama City University Hospital
Kanagawa, 236-0004
JapanSite Not Available
Yokohama City University Hospital
Kanagawa 1860292, 236-0004
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1154
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama 1854383, 701-1154
JapanSite Not Available
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
South KoreaSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, Seoul-teukbyeolsi [seoul] 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul] 03080
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul 1835848, Seoul-teukbyeolsi [seoul] 03722
South KoreaSite Not Available
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla
Santander 3109718, Cantabria 3336898 39008
SpainSite Not Available
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de 28046
SpainSite Not Available
Hospital Universitario La Paz
Madrid 3117735, Madrid, Comunidad de 28046
SpainSite Not Available
Centro de Actividades Ambulatorias
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hammersmith Hospital
London, London, CITY of W12 0HS
United KingdomSite Not Available
Hammersmith Hospital
London 2643743, London, CITY of W12 0HS
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank, G81 4DY
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank 2652730, G81 4DY
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
Royal Free London NHS Foundation Trust, Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
Royal Brompton Hospital
London 2643743, SW3 6NP
United KingdomSite Not Available
Royal Free Hospital
London 2643743, NW3 2QC
United KingdomSite Not Available
Royal Free London NHS Foundation Trust, Royal Free Hospital
London 2643743, NW3 2QG
United KingdomSite Not Available
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesSite Not Available
UCI Health - Costa Mesa
Costa Mesa, California 92627
United StatesSite Not Available
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California 92868
United StatesSite Not Available
University of California, Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
UC Davis Health Medical Center
Sacramento, California 95817
United StatesSite Not Available
University of California Davis Health
Sacramento, California 95817
United StatesSite Not Available
UCSF Health St. Mary's Hospital
San Francisco, California 94117
United StatesSite Not Available
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143
United StatesSite Not Available
Anaheim Clinical Trials, LLC
Anaheim 5323810, California 5332921 92801
United StatesSite Not Available
UCI Health - Costa Mesa
Costa Mesa 5339840, California 5332921 92627
United StatesSite Not Available
UCI Health Center for Innovative Health Therapies (CIHT)
Orange 5379513, California 5332921 92868
United StatesSite Not Available
University of California, Irvine Medical Center
Orange 5379513, California 5332921 92868
United StatesSite Not Available
UC Davis Health Medical Center
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
University of California Davis Health
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
UCSF Health St. Mary's Hospital
San Francisco 5391959, California 5332921 94117
United StatesSite Not Available
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Norton Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Hospital
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Icahn school of medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
Icahn school of medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina 27514
United StatesSite Not Available
UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina 27514
United StatesSite Not Available
UNC Hospitals
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Investigational Drug Services Pharmacy
Morrisville, North Carolina 27560
United StatesSite Not Available
Eastowne 100 Medical Office Building
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
UNC Health - Eastowne Medical Office
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
UNC Hospitals
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
Investigational Drug Services Pharmacy
Morrisville 4480285, North Carolina 4482348 27560
United StatesSite Not Available
Center for Advanced Lung Care
Providence, Rhode Island 02904
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Center for Advanced Lung Care
Providence 5224151, Rhode Island 5224323 02904
United StatesSite Not Available
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina - Nexus
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina - Radiology
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Medical University of South Carolina - Nexus
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Medical University of South Carolina - Radiology
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Medical University of South Carolina-Nexus
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available

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