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A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension - Trial NCT06137742

Access comprehensive clinical trial information for NCT06137742 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pfizer and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 90 participants.

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NCT06137742
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06137742
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A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
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

Study Focus

PF-07868489

Interventional

drug

Sponsor & Location

Pfizer

Timeline & Enrollment

Phase 1

Nov 14, 2023

Apr 07, 2026

90 participants

Primary Outcome

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs),Number of Participants With Change From Baseline in Laboratory Tests Results,Number of Participants With Vital Sign Abnormalities,Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters,Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs),Number of Participants With Change From Baseline in Laboratory Tests Results,Number of Participants With Vital Sign Abnormalities,Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

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.

ICD-10 Classifications

Primary pulmonary hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT06137742

Non-Device Trial