HealthyPhase 1NCT00736528
A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
A Phase 1 study testing PF-04447943 in people with Healthy and Elderly, run by Pfizer at 1 site in United States.
Trial summary
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- What is being tested?
- PF-04447943
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy
- Elderly
- 65-85
Who cannot join
- Evidence or history of clinically significant unstable disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Gainesville, Florida, 32608
About this study
Official title: An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.
Read the detailed description
Additional Study Purpose Details: Phase I safety and pharmacokinetics study.
Detailed Description:
The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.
- Being tested
- PF-04447943, Placebo
- Keywords
- safety, tolerability, pharmacokinetics, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04447943Drug
05 mg BID for 14 days
PF-04447943Drug
15 mg BID for 14 days
PF-04447943Drug
45mg BID for 14 days
PlaceboDrug
Placebo for 14 days
| Study group | Role | What they receive |
|---|---|---|
| PF-04447943 05 mg dose | Experimental | Not described Receives: Drug: PF-04447943 |
| PF-04447943 15 mg dose | Experimental | Not described Receives: Drug: PF-04447943 |
| PF-04447943 45 mg dose | Experimental | Not described Receives: Drug: PF-04447943 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
Measured: 14 days
Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
Measured: 14 days
Secondary outcomes (1)
Changes in cognition from baseline
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: See Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT00736528
- Sponsor's protocol ID
- B0401002
- Status last verified
- Feb 2009
- First submitted
- 15 Aug 2008
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT00736528
- Acronym / sponsor ID
- B0401002
- Keywords
- safety, tolerability, pharmacokinetics, cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description for termination reason.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Aug 2008 (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.
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.
Detailed description
Additional Study Purpose Details: Phase I safety and pharmacokinetics study.
Detailed Description:
The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-04447943 05 mg dose | Experimental | Drug: PF-04447943 |
| PF-04447943 15 mg dose | Experimental | Drug: PF-04447943 |
| PF-04447943 45 mg dose | Experimental | Drug: PF-04447943 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy
- Elderly
- 65-85
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant unstable disease
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 |
|---|---|---|
| PF-0444794305 mg BID for 14 days | Drug | PF-04447943 05 mg dose |
| PF-0444794315 mg BID for 14 days | Drug | PF-04447943 15 mg dose |
| PF-0444794345mg BID for 14 days | Drug | PF-04447943 45 mg dose |
| PlaceboPlacebo for 14 days | Drug | Placebo |
Primary outcome
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
Time frame: 14 days
Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
Time frame: 14 days
1 secondary outcome
Changes in cognition from baseline
Time frame: 14 days
Results and safety
The study was stopped early (reason given: See Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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 PF-04447943 in people with Healthy and Elderly, 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Feb 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: See Detailed Description for termination reason.). Results are not available in the source record.
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?
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints (time frame: 14 days). The study lists 2 primary outcomes in all. 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 25 Feb 2009.