First Safety Study in Humans of a Single Dose of CPG 52364
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: 52364 3 mgDrug: 52364 30 mgDrug: 52364 1 mgDrug: 52364 100 mgDrug: 52364 10 mg
- Registration Number
- NCT00547014
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 52364 3 mg - Cohort 4 52364 30 mg - Cohort 1 1mg 52364 1 mg - Cohort 5 52364 100 mg - Cohort 3 52364 10 mg -
- Primary Outcome Measures
Name Time Method Clinical Assessment of Adverse Events 28 days/subject
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Parameters 28 days/subject
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Overland Park, Kansas, United States