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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

A PHASE 1, 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 REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137742
• Other study ID #: C5001001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 17, 2023
• Est. completion date: September 18, 2026

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 18, 2026
• Est. primary completion date: September 18, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• PF-07868489
Experimental Treatment
• Placebo for PF-07868489
Placebo

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Part A	Baseline up to Day 113.
Primary	Number of Participants With Change From Baseline in Laboratory Tests Results	Part A	Baseline up to Day 113
Primary	Number of Participants With Vital Sign Abnormalities	Part A	Baseline up to Day 113
Primary	Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters	Part A	Baseline up to Day 113
Primary	Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Part B	Baseline up to Day 281
Primary	Number of Participants With Change From Baseline in Laboratory Tests Results	Part B	Baseline up to Day 281
Primary	Number of Participants With Vital Sign Abnormalities	Part B	Baseline up to Day 281
Primary	Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters	Part B	Baseline up to Day 281
Secondary	Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)	single dose	Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	single dose	Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary	Maximum Observed Plasma Concentration (Cmax)	single dose	Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	single dose	4-7 days
Secondary	Incidence of Anti-Drug Antibody (ADA)	single dose	Baseline and up to week 16
Secondary	Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24	repeated doses	Baseline, week 24
Secondary	Plasma Decay Half-Life (t1/2)	single dose	20 days
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)	repeat doses	week 4
Secondary	Plasma Decay Half-Life (t1/2)	repeat doses	20 days
Secondary	Incidence of Anti-Drug Antibody (ADA)	repeated doses	Baseline and up to week 40

External Links

•   To obtain contact information for a study center near you, click here.