NCT03860506

Brief Summary

This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

January 22, 2018

Last Update Submit

February 28, 2019

Conditions

Healthy

Keywords

healthy subjects who smokehealthy subjects

Outcome Measures

Primary Outcomes (1)

  • reduction of platelet monocyte aggregates

    2 days

Study Arms (2)

PSI-697

EXPERIMENTAL
Drug: PSI-697

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PSI-697DRUG
PSI-697
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 3 cigarettes) for more than 1 year as determined by history.

You may not qualify if:

  • Any diagnosed bleeding disorder.
  • Any major surgical procedure within 6 months before study day 1.
  • Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

2-(4-chlorobenzyl)-3-hydroxy-7,8,9,10-tetrahydrobenzo(H)quinoline-4-carboxylic acid

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

March 4, 2019

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 4, 2019

Record last verified: 2019-02