Not currently recruiting at University of California Health

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

a study on High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension

Summary

Eligibility
for people ages 18-65 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Christopher Barnett (ucsf)
Headshot of Christopher Barnett
Christopher Barnett

Description

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

Keywords

Pulmonary Arterial Hypertension, pulmonary, high lung artery pressure, Counterfeit Drugs

Eligibility

You can join if…

Open to people ages 18-65

Part A:

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

You CAN'T join if...

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 32 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.

Locations

  • UCSF Helen Diller Medical Center at Parnassus Heights not yet accepting patients
    San Francisco 5391959 California 5332921 94143 United States
  • Anaheim Clinical Trials, LLC in progress, not accepting new patients
    Anaheim 5323810 California 5332921 92801 United States
  • St. Marianna University Hospital accepting new patients
    Kawasaki 1859642 Kanagawa 1860291 216-8511 Japan
  • Tohoku University Hospital accepting new patients
    Sendai 2111149 Miyagi 2111888 980-8574 Japan
  • Yokohama City University Hospital not yet accepting patients
    Kanagawa 1860292 236-0004 Japan
  • National Hospital Organization Okayama Medical Center accepting new patients
    Okayama 1854383 701-1154 Japan

Lead Scientist at University of California Health

  • Christopher Barnett (ucsf)
    Dr. Barnett is certified in critical care medicine, cardiology and advanced heart failure/pulmonary hypertension. The field of critical care cardiology is a new and emerging specialty in cardiology.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT06137742
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated