Investigating PF-07868489 in healthy adults and those with pulmonary arterial hypertension
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
This study is testing a new drug called PF-07868489 to see if it's safe and effective for people with pulmonary arterial hypertension and healthy adults.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 14 sites (Anaheim, California and 13 other locations) |
| Trial ID | NCT06137742 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, tolerability, and pharmacokinetics of the investigational drug PF-07868489 in both healthy adults and individuals diagnosed with pulmonary arterial hypertension (PAH). It consists of two parts: the first part is a single ascending dose study in healthy participants, while the second part is a randomized, double-blind, placebo-controlled study assessing the drug's effects over 24 weeks in PAH patients. Participants will receive either the study medication or a placebo to determine the drug's impact on their condition.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with pulmonary arterial hypertension who are stable on standard care therapies.
Not a fit: Patients with significant comorbidities or those not currently receiving standard supportive therapy for pulmonary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with pulmonary arterial hypertension.
How similar studies have performed: Other studies have shown promise in evaluating new treatments for pulmonary arterial hypertension, making this approach potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Anaheim, California and 13 other locations
- Anaheim Clinical Trials, LLC — Anaheim, California, United States (Active_not_recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Not_yet_recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- Kobe University Hospital — Kobe, Hyogo, Japan (Not_yet_recruiting)
- St. Marianna University Hospital — Kawasaki, Kanagawa, Japan (Not_yet_recruiting)
- Tohoku University Hospital — Sendai, Miyagi, Japan (Not_yet_recruiting)
- Yokohama City University Hospital — Kanagawa, Japan (Not_yet_recruiting)
- National Hospital Organization Okayama Medical Center — Okayama, Japan (Not_yet_recruiting)
- Gachon University Gil Medical Center — Namdong-gu, Incheon-gwangyeoksi [incheon], Korea, Republic of (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of (Not_yet_recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of (Not_yet_recruiting)
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of (Not_yet_recruiting)
- Hammersmith Hospital — London, London, CITY OF, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.