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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00547014
First received: October 18, 2007
Last updated: March 18, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Placebo Comparator: Cohort 1 Placebo
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
Drug: 52364 1 mg
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Assessment of Adverse Events [ Time Frame: 28 days/subject ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic Parameters [ Time Frame: 28 days/subject ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: September 2007
Study Completion Date: April 2008
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547014

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00547014     History of Changes
Other Study ID Numbers: B1221001, 52364-002
Study First Received: October 18, 2007
Last Updated: March 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)

ClinicalTrials.gov processed this record on April 17, 2014