First Safety Study in Humans of a Single Dose of CPG 52364
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00547014
First received: October 18, 2007
Last updated: March 18, 2009
Last verified: March 2009
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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 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 May 16, 2013