Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06137742
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-11-14
Brief Title:
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 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 REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None