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

Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo Comparator: Cohort 1 Placebo; Drug: 52364 1 mg; 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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 2	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
Experimental: Cohort 3	Drug: 52364 10 mg; Drug: 52364 30 mg capsule as a single dose
Experimental: Cohort 4	Drug: 52364 30 mg; Drug: 52364 30 mg capsule administered as a single dose
Experimental: Cohort 5	Drug: 52364 100 mg; Drug 52364 100 mg capsule administered as a single dose
Experimental: Cohort 1 1mg	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic Parameters	28 days/subject

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: October 18, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (Estimate): October 19, 2007

Study Record Updates

• Last Update Posted (Estimate): March 19, 2009
• Last Update Submitted That Met QC Criteria: March 18, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
• Other Study ID Numbers: B1221001; 52364-002