A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
Pulmonary Arterial Hypertension
Спонсор: Pfizer
Налично на:
БГ
Обобщение
The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH).
Part A:
An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants.
Part B:
A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.
Кой може да участва
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.
Интервенции
PF-07868489
DRUG
Placebo for PF-07868489
DRUG
Места на провеждане
67
Австралия (3)
Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower , Queensland
Wesley Research Institute
Auchenflower , Queensland
Royal Prince Alfred Hospital
Camperdown , New South Wales
Белгия (2)
Université Libre de Bruxelles - Hôpital Erasme
Brussels , Bruxelles-capitale, Région de
UZ Leuven
Leuven , Vlaams-brabant
Канада (2)
London Health Sciences Centre - Verspeeten Family Cancer Centre
London , Ontario
London Health Sciences Centre - University Hospital
London , Ontario
Китай (4)
The Second Xiangya Hospital of Central South University
Changsha , Hunan
Guangdong Provincial People's Hospital
Guangzhou , Guangdong
Zhongda Hospital Southeast University
Nanjing , Jiangsu
Shanghai Pulmonary Hospital
Shanghai , Shanghai Municipality
Чехия (2)
Vseobecna fakultni nemocnice v Praze
Prague
Institut Klinicke a Experimentalni Mediciny
Prague
Франция (4)
CHRU de Brest
Brest , Finistère
CHRU de Brest
Brest , Finistère
Chu Grenoble Alpes
La Tronche
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez , Pays de la Loire Region
Германия (5)
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden , Saxony
UKGM Gießen/Marburg
Giessen , Hesse
Universitätsmedizin Greifswald
Greifswald , Mecklenburg-Vorpommern
Thoraxklinik-Heidelberg gGmbH
Heidelberg , Baden-Wurttemberg
Universitätsklinikum Regensburg
Regensburg , Bavaria
Гърция (3)
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári , Attikí
Onassis Hospital
Kallithea , Attica
AHEPA University General Hospital of Thessaloniki
Thessaloniki , Central Macedonia
Италия (3)
Fondazione IRCCS San Gerardo dei Tintori
Monza , Monza E Brianza
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo
Fondazione IRCCS Policlinico San Matteo
Pavia
Япония (5)
Yokohama City University Hospital
Kanagawa
St. Marianna University Hospital
Kawasaki , Kanagawa
Kobe University Hospital
Kobe , Hyōgo
National Hospital Organization Okayama Medical Center
Okayama
Tohoku University Hospital
Sendai , Miyagi
Южна Корея (4)
Gachon University Gil Medical Center
Namdong-gu , Incheon-gwangyeoksi [incheon]
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Severance Hospital, Yonsei University Health System
Seoul , Seoul-teukbyeolsi [seoul]
Samsung Medical Center
Seoul , Seoul-teukbyeolsi [seoul]
Испания (3)
Hospital Universitario La Paz
Madrid , Madrid, Comunidad de
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Marqués de Valdecilla
Santander , Cantabria
Великобритания (4)
Golden Jubilee National Hospital
Clydebank
Hammersmith Hospital
London , London, CITY of
Royal Free London NHS Foundation Trust, Royal Free Hospital
London
Royal Brompton Hospital
London
САЩ (23)
Anaheim Clinical Trials, LLC
Anaheim , California
University of Colorado Anschutz Medical Campus
Aurora , Colorado
Eastowne 100 Medical Office Building
Chapel Hill , North Carolina
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill , North Carolina
UNC Health - Eastowne Medical Office
Chapel Hill , North Carolina
UNC Hospitals
Chapel Hill , North Carolina
Medical University of South Carolina - Nexus
Charleston , South Carolina
Medical University of South Carolina - Radiology
Charleston , South Carolina
Medical University of South Carolina
Charleston , South Carolina
UCI Health - Costa Mesa
Costa Mesa , California
Norton Hospital
Louisville , Kentucky
Norton Pulmonary Specialists
Louisville , Kentucky
Investigational Drug Services Pharmacy
Morrisville , North Carolina
Icahn school of medicine at Mount Sinai
New York , New York
Mount Sinai Hospital
New York , New York
UCI Health Center for Innovative Health Therapies (CIHT)
Orange , California
University of California, Irvine Medical Center
Orange , California
Rhode Island Hospital
Providence , Rhode Island
Center for Advanced Lung Care
Providence , Rhode Island
UC Davis Health Medical Center
Sacramento , California
University of California Davis Health
Sacramento , California
UCSF Helen Diller Medical Center at Parnassus Heights