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ACTIVE NOT RECRUITING
NCT06137742
PHASE1/PHASE2

A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension

Sponsor: Pfizer

View on ClinicalTrials.gov

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

96

Start Date

2023-11-17

Completion Date

2026-09-02

Last Updated

2026-04-07

Healthy Volunteers

Yes

Interventions

DRUG

PF-07868489

Experimental Treatment

DRUG

Placebo for PF-07868489

Placebo

Locations (66)

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

UC Davis Health Medical Center

Sacramento, California, United States

University of California Davis Health

Sacramento, 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

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Norton Hospital

Louisville, Kentucky, United States

Norton Pulmonary Specialists

Louisville, Kentucky, 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

Rhode Island Hospital

Providence, Rhode Island, United States

Center for Advanced Lung Care

Providence, Rhode Island, 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

Wesley Research Institute

Auchenflower, Queensland, Australia

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Bruxelles-capitale, Région de, Belgium

UZ Leuven

Leuven, Vlaams-brabant, Belgium

London Health Sciences Centre - Verspeeten Family Cancer Centre

London, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

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

Institut Klinicke a Experimentalni Mediciny

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

Chu Grenoble Alpes

La Tronche, 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

Onassis Hospital

Kallithea, Attica, Greece

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Central Macedonia, Greece

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, Italy

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

Yokohama City University Hospital

Kanagawa, 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 Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hammersmith Hospital

London, London, CITY of, United Kingdom

Golden Jubilee National Hospital

Clydebank, United Kingdom

Royal Free London NHS Foundation Trust, Royal Free Hospital

London, United Kingdom

Royal Brompton Hospital

London, United Kingdom