First Safety Study in Humans of a Single Dose of CPG 52364 | NCT00547014

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

NCT00547014

Sponsor

Pfizer

Status

Completed

Last Update Posted

Mar 19, 2009Estimated

Enrollment

61Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Placebo Comparator: Cohort 1 Placebo
52364 3 mg
Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
52364 10 mg
52364 30 mg
52364 100 mg
52364 1 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
52364-002

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Oct 18, 2007

First Submission Date that Met QC Criteria

Oct 18, 2007

First Posted Date

Oct 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort 1 1mg	Experimental	Drug: Placebo Comparator: Cohort 1 Placebo Drug: 52364 1 mg
Cohort 2	Experimental	Drug: 52364 3 mg Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
Cohort 3	Experimental	Drug: 52364 10 mg
Cohort 4	Experimental	Drug: 52364 30 mg
Cohort 5	Experimental	Drug: 52364 100 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo Comparator: Cohort 1 Placebo	Drug	Drug: placebo for cohort 1 as single dose	Cohort 1 1mg

Measure	Description	Time Frame
Clinical Assessment of Adverse Events		28 days/subject

Measure	Description	Time Frame
Pharmacokinetic Parameters		28 days/subject

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Overland Park	Kansas	66211	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided