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

Pfizer61 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Placebo Comparator: Cohort 1 PlaceboDRUG

Drug: placebo for cohort 1 as single dose

52364 3 mgDRUG

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 placeboDRUG

Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Clinical Assessment of Adverse Events

Time frame: 28 days/subject

Secondary Outcomes

Pharmacokinetic Parameters

Time frame: 28 days/subject

Data from ClinicalTrials.gov

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