A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in Peopl… (NCT06137742) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
United States97 participantsStarted 2023-11-17
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Key Inclusion Criteria Part A:
* overtly healthy
* Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.
Key Exclusion Criteria Part A:
* clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
* smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.
Key Inclusion Criteria Part B:
* diagnosis of pulmonary arterial hypertension (PAH)
* stable dose of standard of care PAH vasodilators
* BMI 16 to 40 kg/m2; and a total body weight \>45 kg.
* 6MWD ≥ 150 and ≤ 450.
* Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.
Key Exclusion Criteria Part B:
* Any medical or psychiatric condition or laboratory abnormality.
* Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
* Pulmonary capillary wedge pressure \> 15 mmHg on right heart catheterization (RHC) conducted during Screening.
* History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
* Major surgery within 8 weeks prior to randomization.
* Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline up to Day 113.
2
Number of Participants With Change From Baseline in Laboratory Tests Results
Timeframe: Baseline up to Day 113
3
Number of Participants With Vital Sign Abnormalities
Timeframe: Baseline up to Day 113
4
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Timeframe: Baseline up to Day 113
5
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline up to Day 253
6
Number of Participants With Change From Baseline in Laboratory Tests Results
Timeframe: Baseline up to Day 253
7
Number of Participants With Vital Sign Abnormalities
Timeframe: Baseline up to Day 253
8
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters