A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: Placebo for PF-07868489
- Registration Number
- NCT06137742
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo for PF-07868489 single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B) PF-07868489 PF-07868489 single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Day 253 Part B
Number of Participants With Change From Baseline in Laboratory Tests Results Baseline up to Day 253 Part B
Number of Participants With Vital Sign Abnormalities Baseline up to Day 253 Part B
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters Baseline up to Day 253 Part B
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24 Baseline, Week 24 repeated doses
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose single dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose single dose
Maximum Observed Plasma Concentration (Cmax) Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose single dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) 4-7 days single dose
Incidence of Anti-Drug Antibody (ADA) Baseline and up to Day 253 repeated doses
Plasma Decay Half-Life (t1/2) Day 253 repeat doses
Minimum Observed Plasma Trough Concentration (Cmin) Day 253 repeat doses
PVR Baseline, Week 24 repeated doses
6MWD Baseline, Week 24 repeated doses
Trial Locations
- Locations (27)
UCSF Helen Diller Medical Center at Parnassus Heights
🇺🇸San Francisco, California, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Center for Advanced Lung Care
🇺🇸Providence, Rhode Island, United States
Wesley Research Institute
🇦🇺Auchenflower, Queensland, Australia
Université Libre de Bruxelles - Hôpital Erasme
🇧🇪Brussels, Bruxelles-capitale, Région DE, Belgium
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Baden-württemberg, Germany
UKGM Gießen/Marburg
🇩🇪Gießen, Hessen, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
🇩🇪Dresden, Sachsen, Germany
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Monza E Brianza, Italy
Scroll for more (17 remaining)UCSF Helen Diller Medical Center at Parnassus Heights🇺🇸San Francisco, California, United States