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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
97
Experimental Treatment
Placebo
Anaheim Clinical Trials, LLC
Anaheim, California, United States
UCI Health - Costa Mesa
Costa Mesa, California, United States
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, United States
University of California, Irvine Medical Center
Orange, California, United States
UCSF Health St. Mary's Hospital
San Francisco, California, United States
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part A
Time frame: Baseline up to Day 113.
Number of Participants With Change From Baseline in Laboratory Tests Results
Part A
Time frame: Baseline up to Day 113
Number of Participants With Vital Sign Abnormalities
Part A
Time frame: Baseline up to Day 113
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Part A
Time frame: Baseline up to Day 113
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part B
Time frame: Baseline up to Day 253
Number of Participants With Change From Baseline in Laboratory Tests Results
Part B
Time frame: Baseline up to Day 253
Number of Participants With Vital Sign Abnormalities
Part B
Time frame: Baseline up to Day 253
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Part B
Time frame: Baseline up to Day 253
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24
repeated doses
Time frame: Baseline, Week 24
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
single dose
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
single dose
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Maximum Observed Plasma Concentration (Cmax)
single dose
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
single dose
Time frame: 4-7 days
Incidence of Anti-Drug Antibody (ADA)
single dose
Time frame: Baseline and up to week 16
Plasma Decay Half-Life (t1/2)
single dose
Time frame: Day 113
Minimum Observed Plasma Trough Concentration (Cmin)
repeat doses
Time frame: Day 253
Plasma Decay Half-Life (t1/2)
repeat doses
Time frame: Day 253
Incidence of Anti-Drug Antibody (ADA)
repeated doses
Time frame: Baseline and up to Day 253
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24
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UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Icahn school of medicine at Mount Sinai
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, United States
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, United States
...and 36 more locations
repeated doses
Time frame: Baseline, Week 24
6MWD
repeated doses
Time frame: Baseline, Week 24