Healthy VolunteersPhase 1NCT00547014
First Safety Study in Humans of a Single Dose of CPG 52364
A Phase 1 study testing 52364 3 mg, 52364 10 mg and 52364 30 mg in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 52364 3 mg, 52364 10 mg and 52364 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Overland Park, Kansas, 66211
About this study
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
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
- Being tested
- Placebo Comparator: Cohort 1 Placebo, 52364 3 mg, Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo, 52364 10 mg, 52364 30 mg
- Keywords
- treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
52364 10 mgDrug
Drug: 52364 30 mg capsule as a single dose
52364 30 mgDrug
Drug: 52364 30 mg capsule administered as a single dose
52364 100 mgDrug
Drug 52364 100 mg capsule administered as a single dose
52364 1 mgDrug
1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 1mg | Experimental | Not described Receives: Drug: Placebo Comparator: Cohort 1 Placebo; Drug: 52364 1 mg |
| Cohort 2 | Experimental | Not described Receives: 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 | Not described Receives: Drug: 52364 10 mg |
| Cohort 4 | Experimental | Not described Receives: Drug: 52364 30 mg |
| Cohort 5 | Experimental | Not described Receives: Drug: 52364 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment of Adverse Events
Measured: 28 days/subject
Secondary outcomes (1)
Pharmacokinetic Parameters
Measured: 28 days/subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startSep 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547014
- Sponsor's protocol ID
- B1221001
- Other IDs
- 52364-002
- Status last verified
- Mar 2009
- First submitted
- 18 Oct 2007
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00547014
- Acronym / sponsor ID
- B1221001
- Conditions
- Healthy Volunteers
- Keywords
- treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Comparator: Cohort 1 PlaceboDrug: placebo for cohort 1 as single dose | Drug | Cohort 1 1mg |
| 52364 3 mg3 mg capsule single dose administered orally as a single dose | Drug | Cohort 2 |
| Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placeboDrug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose | Drug | Cohort 2 |
| 52364 10 mgDrug: 52364 30 mg capsule as a single dose | Drug | Cohort 3 |
| 52364 30 mgDrug: 52364 30 mg capsule administered as a single dose | Drug | Cohort 4 |
| 52364 100 mgDrug 52364 100 mg capsule administered as a single dose | Drug | Cohort 5 |
| 52364 1 mg1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose | Drug | Cohort 1 1mg |
Primary outcome
Clinical Assessment of Adverse Events
Time frame: 28 days/subject
1 secondary outcome
Pharmacokinetic Parameters
Time frame: 28 days/subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 52364 3 mg, 52364 10 mg and 52364 30 mg in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment of Adverse Events (time frame: 28 days/subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009; AzTrials last refreshed its copy on 26 Oct 2026.