HealthyPhase 1NCT01097876
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer Subjects
A Phase 1 study testing PF-04447943 25 mg in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04447943 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2010to Jul 2010
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female of non-childbearing potential subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Pregnant or nursing females; females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil
The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
Read the detailed description
Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
- Conditions
- Healthy
- Being tested
- PF-04447943 25 mg, Placebo PF
- Keywords
- healthy volunteer, pharmacokinetic, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04447943 25 mgDrug
25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3)
Placebo PFDrug
Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)
| Study group | Role | What they receive |
|---|---|---|
| Active PF-04447943 | Experimental | Not described Receives: Drug: PF-04447943 25 mg |
| Placebo PF-04447943 | Placebo comparator | Not described Receives: Drug: Placebo PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state PF 04447943 Cmax and AUCtau.
Measured: up through day 44
Steady state Donepezil Cmax and AUCtau.
Measured: up through day 44
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.
Measured: up through day 44
Secondary outcomes (1)
There are no Secondary Endpoints
Measured: There are no Secondary Endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01097876
- Sponsor's protocol ID
- B0401012
- Status last verified
- Aug 2010
- First submitted
- 23 Mar 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil
- ClinicalTrials.gov ID
- NCT01097876
- Acronym / sponsor ID
- B0401012
- Conditions
- Healthy
- Keywords
- healthy volunteer, pharmacokinetic, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Apr 2010 (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.
The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
Detailed description
Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PF-04447943 | Experimental | Drug: PF-04447943 25 mg |
| Placebo PF-04447943 | Placebo comparator | Drug: Placebo PF |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female of non-childbearing potential subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Pregnant or nursing females; females of childbearing potential.
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-04447943 25 mg25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3) | Drug | Active PF-04447943 |
| Placebo PFPlacebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3) | Drug | Placebo PF-04447943 |
Primary outcome
Steady state PF 04447943 Cmax and AUCtau.
Time frame: up through day 44
Steady state Donepezil Cmax and AUCtau.
Time frame: up through day 44
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.
Time frame: up through day 44
1 secondary outcome
There are no Secondary Endpoints
Time frame: There are no Secondary Endpoints
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 4 Aug 2010.
- 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 PF-04447943 25 mg in people with Healthy, run by Pfizer at 1 site in Singapore.
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 1 inclusion and 2 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 4 Aug 2010. 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 Singapore. 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 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?
Steady state PF 04447943 Cmax and AUCtau. (time frame: up through day 44). The study lists 3 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 4 Aug 2010; AzTrials last refreshed its copy on 6 Nov 2026.