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NCT06137742CompletedPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
97 (actual)
First submitted
14 Nov 2023
Start date
17 Nov 2023
Primary completion date
31 Jul 2026
Lead sponsor
Pfizer
NCT number
NCT06137742
EU CT number
2024-514064-17-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 97
  • From 17 Nov 2023 to the primary completion date, 31 Jul 2026
  • 53 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
  • 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.

Other illness

  • clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
  • Pulmonary capillary wedge pressure \> 15 mmHg on right heart catheterization (RHC) conducted during Screening.

Lab values

  • Any medical or psychiatric condition or laboratory abnormality.

Other

  • smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.
  • Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.

Who the study is looking for

  • overtly healthy
  • Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.
  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wesley Research Institute
Coordinator of this site? Confirm its status
AuchenflowerAustraliaUnknown status
Pulmonary Hypertension Research Queensland Pty Ltd
Coordinator of this site? Confirm its status
AuchenflowerAustraliaUnknown status
Royal Prince Alfred Hospital
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Hopital Erasme
Coordinator of this site? Confirm its status
AnderlechtBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Institute for Clinical and Experimental Medicine
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PragueCzechiaCompleted
Technische Universitaet Dresden
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DresdenGermanyCompleted
Universitaetsklinikum Giessen und Marburg GmbH
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GiessenGermanyCompleted
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Hammersmith Hospital
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LondonUnited KingdomUnknown status
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceCompleted
Onassis Cardiac Surgery Center
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KallitheaGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.
Coordinator of this site? Confirm its status
PalermoItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
St. Marianna University Hospital
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KawasakiJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
National Hospital Organization Okayama Medical Center
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OkayamaJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Gachon University Gil Medical Center
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Namdong-guSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Anaheim Clinical Trials, LLC
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AnaheimUnited StatesUnknown status
Eastowne 100 Medical Office Building
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Chapel HillUnited StatesUnknown status
UNC Hospitals
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Chapel HillUnited StatesUnknown status
UNC Health - Eastowne Medical Office
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Chapel HillUnited StatesUnknown status
Eastowne Medical Office Building - Clinical Research Unit
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina - Nexus
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CharlestonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Medical University of South Carolina - Radiology
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CharlestonUnited StatesUnknown status
UCI Health - Costa Mesa
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Costa MesaUnited StatesUnknown status
Investigational Drug Services Pharmacy
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MorrisvilleUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
UCI Health Center for Innovative Health Therapies (CIHT)
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OrangeUnited StatesUnknown status
University of California Irvine Medical Center
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OrangeUnited StatesUnknown status
UCSF Health St. Mary's Hospital
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San FranciscoUnited StatesUnknown status
UCSF Helen Diller Medical Center at Parnassus Heights
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.