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CompletedNCT00547014Updated Mar 19, 2009

First Safety Study in Humans of a Single Dose of CPG 52364

A Phase 1 interventional study of Placebo Comparator: Cohort 1 Placebo and 52364 3 mg in Healthy Volunteers, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-19.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 581 completed or terminated interventional studies of FDA-regulated products, 380 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal body mass index and weight
  • No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion criteria

Exclusion Criteria:

  • Current illness or history of medical condition affecting the body's function
  • Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
  • Use of any medications during the study
  • Positive TB test
  • Smoking within 6 months
  • Pregnancy or risk of Pregnancy
  • Alcohol or drug misuse within 60 days
  • Sensitivity to quinazolines
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Cohort 1 1mg

    Drug: Placebo Comparator: Cohort 1 Placebo · Drug: 52364 1 mg

  • Experimental
    Cohort 2

    Drug: 52364 3 mg · Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

  • Experimental
    Cohort 3

    Drug: 52364 10 mg

  • Experimental
    Cohort 4

    Drug: 52364 30 mg

  • Experimental
    Cohort 5

    Drug: 52364 100 mg

Interventions

  • DrugPlacebo Comparator: Cohort 1 Placebo

    Drug: placebo for cohort 1 as single dose

  • Drug52364 3 mg

    3 mg capsule single dose administered orally as a single dose

  • DrugPlacebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

    Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

  • Drug52364 10 mg

    Drug: 52364 30 mg capsule as a single dose

  • Drug52364 30 mg

    Drug: 52364 30 mg capsule administered as a single dose

  • Drug52364 100 mg

    Drug 52364 100 mg capsule administered as a single dose

  • Drug52364 1 mg

    1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

06

What researchers measure

Primary outcomes

  1. Clinical Assessment of Adverse Events

    Time frame: 28 days/subject

Secondary outcomes

  1. Pharmacokinetic Parameters

    Time frame: 28 days/subject

07

Study locations

1 site
  • Pfizer Investigational Site
    Overland Park, Kansas 66211, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00547014
Lead sponsor
Pfizer
First posted
Oct 19, 2007
Start date
Sep 2007
Completion
Apr 2008
Last update
Mar 19, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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