Renal Insufficiency, ChronicPhase 1NCT00596518
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
A Phase 1 study testing PF-00734200 in people with Renal Insufficiency, Chronic, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- PF-00734200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2007to Jul 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 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
- Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
- Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
Who cannot join
- Women who are pregnant, nursing or women of childbearing potential
- Subjects with acute renal disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Minneapolis, Minnesota, 55404
Pfizer Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- PF-00734200
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00734200Drug
The drug is administered as a single dose of four 5-mg tablets
| Study group | Role | What they receive |
|---|---|---|
| PF-00734200 | Experimental | Not described Receives: Drug: PF-00734200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time 0 until last observation (AUCtlast)
Measured: 3-6 days
Maximum serum concentration (Cmax)
Measured: 3-6 days
Secondary outcomes (5)
AUC extrapolated to infinity (AUCinf)
Measured: 3-6 days
Time of Cmax (Tmax)
Measured: 3-6 days
Half life (T1/2)
Measured: 3-6 days
Renal clearance (CLr)
Measured: 3-6 days
Hemodialysis clearance (CLd)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596518
- Sponsor's protocol ID
- A7941014
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2008
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function
- ClinicalTrials.gov ID
- NCT00596518
- Acronym / sponsor ID
- A7941014
- Conditions
- Renal Insufficiency, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Jan 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.
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-00734200 | Experimental | Drug: PF-00734200 |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
- Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
- Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
Key exclusion criteria (2 listed)
- Women who are pregnant, nursing or women of childbearing potential
- Subjects with acute renal 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-00734200The drug is administered as a single dose of four 5-mg tablets | Drug | PF-00734200 |
Primary outcome
Area under the curve from time 0 until last observation (AUCtlast)
Time frame: 3-6 days
Maximum serum concentration (Cmax)
Time frame: 3-6 days
5 secondary outcomes
AUC extrapolated to infinity (AUCinf)
Time frame: 3-6 days
Time of Cmax (Tmax)
Time frame: 3-6 days
Half life (T1/2)
Time frame: 3-6 days
Renal clearance (CLr)
Time frame: 3-6 days
Hemodialysis clearance (CLd)
Time frame: 3 days
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 10 Mar 2017.
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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
4 sites 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-00734200 in people with Renal Insufficiency, Chronic, run by Pfizer at 4 sites 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 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Area under the curve from time 0 until last observation (AUCtlast) (time frame: 3-6 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 10 Mar 2017.