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

NCT00547014 | Completed Phase 1

• 2 other identifiers: B122100152364-002
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)

Outcome Measures

Primary Outcomes (1)

• Clinical Assessment of Adverse Events

  28 days/subject

Secondary Outcomes (1)

• Pharmacokinetic Parameters

  28 days/subject

Study Arms (5)

Cohort 1 1mg

EXPERIMENTAL

Drug: Placebo Comparator: Cohort 1 Placebo; Drug: 52364 1 mg

Cohort 2

EXPERIMENTAL

Drug: 52364 3 mg; Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

Cohort 3

EXPERIMENTAL

Drug: 52364 10 mg

Cohort 4

EXPERIMENTAL

Drug: 52364 30 mg

Cohort 5

EXPERIMENTAL

Drug: 52364 100 mg

Interventions

Placebo Comparator: Cohort 1 Placebo DRUG

Drug: placebo for cohort 1 as single dose

Cohort 1 1mg

52364 3 mg DRUG

3 mg capsule single dose administered orally as a single dose

Cohort 2

Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo DRUG

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

Cohort 2

52364 10 mg DRUG

Drug: 52364 30 mg capsule as a single dose

Cohort 3

52364 30 mg DRUG

Drug: 52364 30 mg capsule administered as a single dose

Cohort 4

52364 100 mg DRUG

Drug 52364 100 mg capsule administered as a single dose

Cohort 5

52364 1 mg DRUG

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

Cohort 1 1mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: September 1, 2007
• Study Completion: April 1, 2008
• Last Updated: March 19, 2009

Record last verified: 2009-03

Locations

US (1)