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

Launched by PFIZER · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called PF-07868489 to see how well it is tolerated and how it works in both healthy adults and those with a condition called pulmonary arterial hypertension (PAH). The trial has two parts: the first part involves healthy participants taking a single dose of the medicine to assess its safety and how it moves through the body, while the second part looks at participants with PAH over a 24-week period to evaluate safety, tolerability, and effectiveness compared to a placebo (a treatment that looks like the real medicine but has no active ingredients).

To participate, healthy adults should be between 18 and 65 years old and meet certain health criteria, such as having a healthy body weight and no serious medical conditions. For the second part of the trial, participants must have a confirmed diagnosis of PAH and be stable on their current treatment. Throughout the study, participants will have regular check-ins to monitor their health and response to the medication. If you or someone you know fits these criteria and is interested in participating, this trial could provide valuable information about a potential new treatment for PAH.

Gender

ALL

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 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.