First Safety Study in Humans of a Single Dose of CPG 52364 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00547014

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Placebo Comparator: Cohort 1 Placebo Drug: 52364 3 mg Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo Drug: 52364 10 mg Drug: 52364 30 mg Drug: 52364 100 mg Drug: 52364 1 mg	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study

Further study details as provided by Pfizer:

Primary Outcome Measures:

Clinical Assessment of Adverse Events [ Time Frame: 28 days/subject ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic Parameters [ Time Frame: 28 days/subject ] [ Designated as safety issue: No ]

Enrollment:	61
Study Start Date:	September 2007
Study Completion Date:	April 2008

Arms	Assigned Interventions
Cohort 1 1mg: Experimental	Drug: Placebo Comparator: Cohort 1 Placebo Drug: placebo for cohort 1 as single dose Drug: 52364 1 mg 1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
Cohort 2: Experimental	Drug: 52364 3 mg 3 mg capsule single dose administered orally as a single dose Drug: Placebo 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
Cohort 3: Experimental	Drug: 52364 10 mg Drug: 52364 30 mg capsule as a single dose
Cohort 4: Experimental	Drug: 52364 30 mg Drug: 52364 30 mg capsule administered as a single dose
Cohort 5: Experimental	Drug: 52364 100 mg Drug 52364 100 mg capsule administered as a single dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal body mass index and weight
No significant diseases in the medical history or clinically significant findings on physical exam, ophtalmologic 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547014

Locations

United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1221001, 52364-002
Study First Received:	October 18, 2007
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00547014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Lupus Erythematosus, Systemic
Healthy

ClinicalTrials.gov processed this record on January 16, 2009