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Status:

RECRUITING

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

Lead Sponsor:

Pfizer

Conditions:

Pulmonary Arterial Hypertension

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

PHASE2

Brief 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 investi...

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.

Exclusion

    Key Trial Info

    Start Date :

    November 17 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 13 2027

    Estimated Enrollment :

    90 Patients enrolled

    Trial Details

    Trial ID

    NCT06137742

    Start Date

    November 17 2023

    End Date

    February 13 2027

    Last Update

    December 16 2025

    Active Locations (62)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 16 (62 locations)

    1

    Anaheim Clinical Trials, LLC

    Anaheim, California, United States, 92801

    2

    UCI Health - Costa Mesa

    Costa Mesa, California, United States, 92627

    3

    UCI Health Center for Innovative Health Therapies (CIHT)

    Orange, California, United States, 92868

    4

    University of California, Irvine Medical Center

    Orange, California, United States, 92868