Renal InsufficiencyPhase 1NCT00721422
A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.
A Phase 1 study testing PD 0332334 in people with Renal Insufficiency and Pharmacokinetics, run by Pfizer at 2 sites in United States.
Trial summary
1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body. 2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, 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
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers OR subjects with kidney impairment
Who cannot join
- Receiving hemodialysis
- clinically significant or unstable medical disease other than kidney disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Cypress, California, 90630
Pfizer Investigational Site
Miami, Florida, 33169
About this study
Official title: A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
- To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Read the detailed description
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
- Conditions
- Renal Insufficiency, Pharmacokinetics
- Being tested
- PD 0332334
- Keywords
- Pharmacokinetics of PD 0332334 in subjects with renal insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0332334Drug
Also called imagabalin
50 mg (two 25 mg capsules), single, oral dose
PD 0332334Drug
50 mg (two 25 mg capsules), single, oral dose
PD 0332334Drug
50 mg (two 25 mg capsules), single, oral dose
PD 0332334Drug
50 mg (two 25 mg capsules), single, oral dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Normal | Experimental | Not described Receives: Drug: PD 0332334 |
| Group 2-Mild | Experimental | Not described Receives: Drug: PD 0332334 |
| Group 3-Moderate | Experimental | Not described Receives: Drug: PD 0332334 |
| Group 4-Severe | 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), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Measured: 1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Measured: 5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Measured: 5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Measured: 5 to 17 days depending on cohort
Secondary outcomes (1)
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
Measured: 5 to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Please 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 Renal InsufficiencyStudies 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
- 16 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
- NCT00721422
- Sponsor's protocol ID
- A5361023
- Status last verified
- Feb 2010
- First submitted
- 22 Jul 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 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
- ClinicalTrials.gov ID
- NCT00721422
- Acronym / sponsor ID
- A5361023
- Conditions
- Renal Insufficiency, Pharmacokinetics
- Keywords
- Pharmacokinetics of PD 0332334 in subjects with renal insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Jul 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 investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Detailed description
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1-Normal | Experimental | Drug: PD 0332334 |
| Group 2-Mild | Experimental | Drug: PD 0332334 |
| Group 3-Moderate | Experimental | Drug: PD 0332334 |
| Group 4-Severe | Experimental | Drug: PD 0332334 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers OR subjects with kidney impairment
Key exclusion criteria (2 listed)
- Receiving hemodialysis
- clinically significant or unstable medical disease other than kidney 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 |
|---|---|---|
| PD 0332334Also: imagabalin50 mg (two 25 mg capsules), single, oral dose | Drug | Group 1-Normal |
| PD 033233450 mg (two 25 mg capsules), single, oral dose | Drug | Group 2-Mild |
| PD 033233450 mg (two 25 mg capsules), single, oral dose | Drug | Group 3-Moderate |
| PD 033233450 mg (two 25 mg capsules), single, oral dose | Drug | Group 4-Severe |
Primary outcome
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Time frame: 1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Time frame: 5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Time frame: 5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Time frame: 5 to 17 days depending on cohort
1 secondary outcome
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
Time frame: 5 to 17 days
Results and safety
The study was stopped early (reason given: Please 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 17 Feb 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Renal Insufficiency
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
Acute Kidney Injury (AKI)
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
Not yet recruitingPhase 2
Ticagrelor for Inflammation and Cardiovascular Risk in Patients With Chronic Kidney Disease
Chronic Kidney Disease (CKD)
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
2 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 PD 0332334 in people with Renal Insufficiency and Pharmacokinetics, run by Pfizer at 2 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 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: stopped early, 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 2 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 was stopped early (reason given: Please 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?
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) (time frame: 1 day). The study lists 4 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.