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

NCT06137742

CompletedPhase 1, Phase 2

Sponsor: Pfizer

Conditions: Pulmonary Arterial Hypertension

Interventions: PF-07868489, Placebo for PF-07868489

Countries: United States, Australia, Belgium, China, Czechia, France, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (46)
  • Anaheim, California, United States
  • Costa Mesa, California, United States
  • Orange, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Chapel Hill, North Carolina, United States
  • Chapel Hill, North Carolina, United States
  • Chapel Hill, North Carolina, United States
  • Morrisville, North Carolina, United States
  • Charleston, South Carolina, United States
  • Charleston, South Carolina, United States
  • Charleston, South Carolina, United States
  • Camperdown, New South Wales, Australia
  • Auchenflower, Queensland, Australia
  • Auchenflower, Queensland, Australia
  • Brussels, Bruxelles-capitale, Région de, Belgium
  • Leuven, Vlaams-brabant, Belgium
  • Guangzhou, Guangdong, China
  • Changsha, Hunan, China
  • Nanjing, Jiangsu, China
  • Shanghai, Shanghai Municipality, China
  • Prague, Czechia
  • Brest, Finistère, France
  • Brest, Finistère, France
  • Saint Priest En Jarez, Pays de la Loire Region, France
  • Heidelberg, Baden-Wurttemberg, Germany
  • + 16 more on CT.gov