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NCT00547014 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00547014
Other study ID # B1221001
Secondary ID 52364-002
Status Completed
Phase Phase 1
First received October 18, 2007
Last updated March 18, 2009
Start date September 2007
Est. completion date April 2008

Study information
Verified date March 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo Comparator: Cohort 1 Placebo
Drug: placebo for cohort 1 as single dose
• 52364 3 mg
3 mg capsule single dose administered orally as a single dose
• 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
• 52364 10 mg
Drug: 52364 30 mg capsule as a single dose
• 52364 30 mg
Drug: 52364 30 mg capsule administered as a single dose
• 52364 100 mg
Drug 52364 100 mg capsule administered as a single dose
• 52364 1 mg
1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

Locations
Country Name City State
United States Pfizer Investigational Site Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Assessment of Adverse Events 28 days/subject Yes
Secondary Pharmacokinetic Parameters 28 days/subject No
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