PF-07868489
DrugExperimental Treatment
NCT Number: NCT06137742
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria Part A:
Key Exclusion Criteria Part A:
Key Inclusion Criteria Part B:
Key Exclusion Criteria Part B:
Experimental Treatment
Placebo
Time frame: Baseline up to Day 113.
Part A
Time frame: Baseline up to Day 113
Part A
Time frame: Baseline up to Day 113
Part A
Time frame: Baseline up to Day 113
Part A
Time frame: Baseline up to Day 253
Part B
Time frame: Baseline up to Day 253
Part B
Time frame: Baseline up to Day 253
Part B
Time frame: Baseline up to Day 253
Part B
Time frame: Baseline, Week 24
repeated doses
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
single dose
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
single dose
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
single dose
Time frame: 4-7 days
single dose
Time frame: Baseline and up to week 16
single dose
Time frame: Day 113
single dose
Time frame: Day 253
repeat doses
Time frame: Day 253
repeat doses
Time frame: Baseline and up to Day 253
repeated doses
Time frame: Baseline, Week 24
repeated doses
Time frame: Baseline, Week 24
repeated doses
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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