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PSI-697

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 4, 2019

PSI-697 development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Aug 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

PSI-697 clinical trials

PSI-697 · 1 trial · 1 indication

Phase 1 1
NCT03860506Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who SmokeHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke
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Study Endpoints

Primary Endpoints

reduction of platelet monocyte aggregates
2 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PSI-697EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PSI-697DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: Inclusion Criteria: * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG). * Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus...

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Frequently asked questions about PSI-697

What is PSI-697?

PSI-697 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial evaluating its effects on platelets in healthy male subjects who smoke. The program is early stage, and no approved indication has been disclosed for PSI-697.

Who makes PSI-697?

PSI-697 is made by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 study of PSI-697 in healthy volunteers who smoke. No partner or licensing arrangement for PSI-697 has been disclosed.

What phase is PSI-697 in?

PSI-697 is in Phase 1 development. Its only recorded clinical trial, NCT03860506, was a completed Phase 1 study. PSI-697 is investigational and has not been approved for any indication. No later-phase trials of PSI-697 have been registered.

What clinical trials is PSI-697 in?

PSI-697 has been studied in one clinical trial: NCT03860506, titled Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke. That Phase 1 trial enrolled 30 healthy male volunteers aged 18 years and older, was randomized, double-blind, and placebo-controlled, and is now completed.

How was the PSI-697 platelet study designed?

The Phase 1 study of PSI-697, NCT03860506, was a randomized, double-blind, placebo-controlled trial in 30 healthy male volunteers who smoke, all aged 18 years or older. It evaluated the effects of PSI-697 on platelets. The trial is completed, and no active trials of PSI-697 are ongoing.