← Back to all trials
Completed
NCT06137742
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
Conditions: Pulmonary Arterial Hypertension
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 97
Sponsor: Pfizer
Location: Anaheim Clinical Trials, LLC Anaheim California
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.
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.
Source: ClinicalTrials.gov (NCT06137742). StuddyBuddy aggregates publicly available trial information.