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NCT06137742Not yet recruiting

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
PfizerPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
PF-07868489
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Pfizer
Timeline & enrollment
Phase
Phase 1
Start date
Nov 14, 2023
End date
Apr 07, 2026
Enrollment
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 hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06137742
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.