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PF-07868489 for Pulmonary Arterial Hypertension

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

Awards & highlights

Study Summary

This trial studies how a drug called PF-07868489 is tolerated and works in healthy people and those with pulmonary arterial hypertension (PAH).

Who is the study for?

This trial is for healthy adults and those with pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. Participants should have a BMI between 16 to 32 kg/m2 and weigh over 50 kg. It's not clear who can't join because the exclusion criteria are missing.Check my eligibility

What is being tested?

The study tests PF-07868489, which could potentially treat PAH. Part A involves giving healthy volunteers either this medicine or a placebo in increasing doses to check safety and how the body processes it. Part B gives PAH patients the drug or placebo for 24 weeks to assess safety and effectiveness.See study design

What are the potential side effects?

Specific side effects aren't listed, but common ones may include reactions at injection sites, headaches, dizziness, nausea, or fatigue as seen with similar treatments. The trial aims to determine these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 16 and 32, and I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

Number of Participants With Change From Baseline in Laboratory Tests Results

Number of Participants With Vital Sign Abnormalities

+1 more

Secondary outcome measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PF-07868489Experimental Treatment1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Group II: PlaceboPlacebo Group1 Intervention

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,892 Total Patients Enrolled

16 Trials studying Pulmonary Arterial Hypertension

3,165 Patients Enrolled for Pulmonary Arterial Hypertension

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,110 Total Patients Enrolled

29 Trials studying Pulmonary Arterial Hypertension

4,623 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still seeking participants for this trial?

"Clinicaltrials.gov confirms that this clinical trial is still seeking patients; the study was first posted on November 17th 2023 and has recently been updated to reflect current information as of December 11th 2023."

Answered by AI

Is this trial restricted to those over the age of 70 or can younger adults participate?

"This clinical study is open to adults older than 18 and younger than 65."

Answered by AI

Who meets the requirements to partake in this trial?

"This pulmonary hypertension clinical trial seeks 90 participants, aged between 18 and 65 years old. In addition to current diagnosis of the condition, they must also have an appropriate Body Mass Index (BMI) ranging from 16-32 kg/m2; as well as a total body weight exceeding 50 kilograms."

Answered by AI

What is the end goal of this medical experiment?

"According to the information supplied by Pfizer, the primary outcome this study will measure over a period from Baseline to Day 281 is Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs). The secondary outcomes that need observation comprise Incidence of Anti-Drug Antibody (ADA), Minimum Observed Plasma Trough Concentration (Cmin), and Maximum Observed Plasma Concentration (Cmax)."

Answered by AI

What guarantees can be made regarding the security of PF-07868489?

"Due to the sparse data available on PF-07868489, we have assigned it a score of 1 with regards to safety. This is often seen in Phase 1 trials which lack both evidence for efficacy and established safety protocols."

Answered by AI

Could you provide an estimate of the total participants in this research endeavor?

"Affirmative, the facts hosted on clinicaltrials.gov demonstrate that this medical experiment is presently recruiting participants. This trial was initially shared on November 17th 2023 and has been most recently updated on December 11th 2023; it requires 90 volunteers across 1 site for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137742.

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