Renal DialysisPhase 1NCT00730145
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
A Phase 1 study testing PD-0332334 in people with Renal Dialysis and Pharmacokinetics, run by Pfizer at 1 site in United States.
Trial summary
1. Quantify how much PD-0332334 is removed from the blood with hemodialysis 2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments. 3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Dialysis, Pharmacokinetics
- What is being tested?
- PD-0332334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving regular hemodialysis
- Male or female patients 18 to 65 years
Who cannot join
- Severe heart failure
- Renal transplant or renal allograft
- Illicit drug use (with the exception of prescribed sedatives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
- Quantify how much PD-0332334 is removed from the blood with hemodialysis
- Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
- Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.
Read the detailed description
Assess the elimination of PD-0332334 from the blood with hemodialysis
- Conditions
- Renal Dialysis, Pharmacokinetics
- Being tested
- PD-0332334
- Keywords
- pharmacokinetics, PD-0332334, hemodialysis, renal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-0332334Drug
Also called imagabalin
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
| Study group | Role | What they receive |
|---|---|---|
| PD-0332334 | Experimental | Not described Receives: Drug: PD-0332334 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis
Measured: 0 to 8 days
Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
Measured: 0 to 8 days
Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).
Measured: 0 to 8 days
Secondary outcomes (1)
Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.
Measured: 0 to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT00730145
- Sponsor's protocol ID
- A5361032
- Status last verified
- Feb 2010
- First submitted
- 6 Aug 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT00730145
- Acronym / sponsor ID
- A5361032
- Conditions
- Renal Dialysis, Pharmacokinetics
- Keywords
- pharmacokinetics, PD-0332334, hemodialysis, renal dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 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.
- Quantify how much PD-0332334 is removed from the blood with hemodialysis
- Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
- Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.
Detailed description
Assess the elimination of PD-0332334 from the blood with hemodialysis
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-0332334 | Experimental | Drug: PD-0332334 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving regular hemodialysis
- Male or female patients 18 to 65 years
Key exclusion criteria (3 listed)
- Severe heart failure
- Renal transplant or renal allograft
- Illicit drug use (with the exception of prescribed sedatives)
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 |
|---|---|---|
| PD-0332334Also: imagabalinA single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject | Drug | PD-0332334 |
Primary outcome
Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis
Time frame: 0 to 8 days
Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
Time frame: 0 to 8 days
Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).
Time frame: 0 to 8 days
1 secondary outcome
Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.
Time frame: 0 to 8 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 17 Feb 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 PD-0332334 in people with Renal Dialysis and Pharmacokinetics, 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 3 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 17 Feb 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 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?
Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis (time frame: 0 to 8 days). 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 17 Feb 2010.