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A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
Sponsor: Pfizer
Summary
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.
Official title: A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
97
Start Date
2023-11-17
Completion Date
2026-07-31
Last Updated
2026-08-21
Healthy Volunteers
Yes
Conditions
Interventions
PF-07868489
Experimental Treatment
Placebo for PF-07868489
Placebo
Locations (46)
Anaheim Clinical Trials, LLC
Anaheim, California, United States
UCI Health - Costa Mesa
Costa Mesa, California, United States
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, United States
University of California, Irvine Medical Center
Orange, California, United States
UCSF Health St. Mary's Hospital
San Francisco, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Icahn school of medicine at Mount Sinai
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, United States
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, United States
UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Investigational Drug Services Pharmacy
Morrisville, North Carolina, United States
Medical University of South Carolina - Nexus
Charleston, South Carolina, United States
Medical University of South Carolina - Radiology
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland, Australia
Wesley Research Institute
Auchenflower, Queensland, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-brabant, Belgium
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
CHRU de Brest
Brest, Finistère, France
CHRU de Brest
Brest, Finistère, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, France
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
UKGM Gießen/Marburg
Giessen, Hesse, Germany
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Kobe University Hospital
Kobe, Hyōgo, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hammersmith Hospital
London, London, CITY of, United Kingdom