ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-17
Study Completion:2026-09-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06137742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
United States
UCI Health - Costa Mesa
Costa Mesa, California, 92627
United States
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, 92868
United States
University of California, Irvine Medical Center
Orange, California, 92868
United States
UC Davis Health Medical Center
Sacramento, California, 95817
United States
University of California Davis Health
Sacramento, California, 95817
United States
UCSF Health St. Mary's Hospital
San Francisco, California, 94117
United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Norton Hospital
Louisville, Kentucky, 40202
United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
United States
Icahn school of medicine at Mount Sinai
New York, New York, 10029
United States
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, 27514
United States
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, 27514
United States
UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina, 27514
United States
UNC Hospitals
Chapel Hill, North Carolina, 27514
United States
Investigational Drug Services Pharmacy
Morrisville, North Carolina, 27560
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Center for Advanced Lung Care
Providence, Rhode Island, 02904
United States
Medical University of South Carolina - Nexus
Charleston, South Carolina, 29425
United States
Medical University of South Carolina - Radiology
Charleston, South Carolina, 29425
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17
Study Completion Date2026-09-02

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2026-09-02

Terms related to this study

Keywords Provided by Researchers

  • pulmonary
  • high lung artery pressure

Additional Relevant MeSH Terms

  • Pulmonary Arterial Hypertension