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

NCT00547014 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2009-03-19

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Placebo Comparator: Cohort 1 Placebo

Drug: placebo for cohort 1 as single dose

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

DRUG

52364 10 mg

Drug: 52364 30 mg capsule as a single dose

DRUG

52364 30 mg

Drug: 52364 30 mg capsule administered as a single dose

DRUG

52364 100 mg

Drug 52364 100 mg capsule administered as a single dose

DRUG

52364 1 mg

1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547014 on ClinicalTrials.gov