What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs) like bosentan and macitentan, and phosphodiesterase type 5 inhibitors (PDE-5Is) like sildenafil and tadalafil. Known side effects of ERAs include fluid retention, peripheral edema, and liver impairment. PDE-5Is can cause headaches, flushing, dyspepsia, and visual disturbances. Both classes of drugs aim to improve exercise capacity and hemodynamic parameters but require monitoring for these adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH) that focus on safety, tolerability, pharmacokinetics, and pharmacodynamics. Notable examples include phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, which improve pulmonary hemodynamics and exercise capacity. Endothelin receptor antagonists (ERAs) such as bosentan and ambrisentan target endothelin receptors to reduce vasoconstriction. Additionally, prostacyclin analogs like epoprostenol and treprostinil have been approved for their efficacy in improving hemodynamic parameters and functional capacity. These treatments have been evaluated in various clinical trials to ensure their safety and effectiveness in managing PAH.

What other types of research exist?

Promising novel alternatives to PF-07868489 for PAH patients include TPN171H, a potent and selective PDE5 inhibitor, and the new more thermostable formulation of Flolan (epoprostenol). TPN171H has shown favorable safety, tolerability, and pharmacokinetics in healthy subjects. The new Flolan formulation has demonstrated safety and efficacy in Japanese patients with PAH. Additionally, the pediatric formulation of bosentan evaluated in the FUTURE-2 study offers long-term safety and tolerability data, which may be relevant for broader patient populations.

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PF-07868489 for Pulmonary Hypertension

Phase 1 & 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

Summary

This trial is testing a new medicine called PF-07868489. It aims to see how safe it is and how it behaves in both healthy adults and those with pulmonary arterial hypertension (PAH). The study will help understand how the medicine moves through the body and its effects.

Who is the study for?

This trial is for healthy adults and those with pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. Participants should have a BMI between 16 to 32 kg/m2 and weigh over 50 kg. It's not clear who can't join because the exclusion criteria are missing.

What is being tested?

The study tests PF-07868489, which could potentially treat PAH. Part A involves giving healthy volunteers either this medicine or a placebo in increasing doses to check safety and how the body processes it. Part B gives PAH patients the drug or placebo for 24 weeks to assess safety and effectiveness.

What are the potential side effects?

Specific side effects aren't listed, but common ones may include reactions at injection sites, headaches, dizziness, nausea, or fatigue as seen with similar treatments. The trial aims to determine these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 16 and 32, and I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

Number of Participants With Change From Baseline in Laboratory Tests Results

+2 more

Secondary study objectives

6MWD

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PF-07868489Experimental Treatment1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Group II: PlaceboPlacebo Group1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs), phosphodiesterase type 5 inhibitors (PDE-5Is), and prostacyclin analogs. ERAs work by blocking the effects of endothelin-1, a potent vasoconstrictor, thereby reducing blood vessel constriction and lowering blood pressure in the lungs. PDE-5Is, such as sildenafil and tadalafil, inhibit the enzyme phosphodiesterase type 5, leading to increased levels of cyclic GMP, which causes vasodilation and improved blood flow. Prostacyclin analogs mimic the effects of prostacyclin, a natural vasodilator, and inhibit platelet aggregation, thus improving blood flow and reducing blood pressure in the pulmonary arteries. These mechanisms are vital for PAH patients as they help alleviate symptoms, improve exercise capacity, and enhance overall quality of life.

Targeted Treatments for Pulmonary Arterial Hypertension: Interpreting Outcomes by Network Meta-analysis.