Healthy VolunteersPhase 1NCT01314898
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
A Phase 1 study testing 3 mg PF-03882845, 10 mg PF-03882845 and 30 mg PF-03882845 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 3 mg PF-03882845, 10 mg PF-03882845 and 30 mg PF-03882845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures.
Who cannot join
- Subjects with a supine BP >140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic based on the average of the triplicate
- Serum potassium >=5.1 mmol/L or <3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
- Estimated GFR <60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Double-Blind (Sponsor-Open), Placebo- And Active-Controlled, Single Dose, Crossover Study To Assess Antimineralocorticoid Activity Of Oral Pf-03882845 In Healthy Subjects.
24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.
- Conditions
- Healthy Volunteers
- Being tested
- 3 mg PF-03882845, 10 mg PF-03882845, 30 mg PF-03882845, 100 mg PF-03882845, Spironolactone
- Keywords
- Single dose, cross-over, active-control, placebo control, antimineralocorticoid activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg PF-03882845Drug
3 mg PF-03882845, single oral dose
10 mg PF-03882845Drug
10 mg PF-03882845, single oral dose
30 mg PF-03882845Drug
30 mg PF-03882845, single oral dose
100 mg PF-03882845Drug
100 mg PF-03882845, single oral dose
SpironolactoneDrug
100 mg spironolactone, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: 3 mg PF-03882845; Drug: 10 mg PF-03882845; Drug: 30 mg PF-03882845; Drug: 100 mg PF-03882845; Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
Measured: 0-24hr postdose per period
Secondary outcomes (4)
Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
Measured: 0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
Measured: 0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
Measured: 0-24 hr post dose per period
Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
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
- NCT01314898
- Sponsor's protocol ID
- B0171007
- Other IDs
- B0171007
- Status last verified
- Jul 2011
- First submitted
- 3 Mar 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind (Sponsor-Open), Placebo- And Active-Controlled, Single Dose, Crossover Study To Assess Antimineralocorticoid Activity Of Oral Pf-03882845 In Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01314898
- Acronym / sponsor ID
- B0171007
- Conditions
- Healthy Volunteers
- Keywords
- Single dose, cross-over, active-control, placebo control, antimineralocorticoid activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Mar 2011 (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.
24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: 3 mg PF-03882845, Drug: 10 mg PF-03882845, Drug: 30 mg PF-03882845, Drug: 100 mg PF-03882845, Drug: Spironolactone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures.
Key exclusion criteria (3 listed)
- Subjects with a supine BP >140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic based on the average of the triplicate
- Serum potassium >=5.1 mmol/L or <3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
- Estimated GFR <60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.
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 |
|---|---|---|
| 3 mg PF-038828453 mg PF-03882845, single oral dose | Drug | Treatment |
| 10 mg PF-0388284510 mg PF-03882845, single oral dose | Drug | Treatment |
| 30 mg PF-0388284530 mg PF-03882845, single oral dose | Drug | Treatment |
| 100 mg PF-03882845100 mg PF-03882845, single oral dose | Drug | Treatment |
| Spironolactone100 mg spironolactone, single oral dose | Drug | Treatment |
Primary outcome
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
Time frame: 0-24hr postdose per period
4 secondary outcomes
Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
Time frame: 0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
Time frame: 0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
Time frame: 0-24 hr post dose per period
Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.
Time frame: 2 months
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 6 Jul 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
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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 3 mg PF-03882845, 10 mg PF-03882845 and 30 mg PF-03882845 in people with Healthy Volunteers, 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 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 6 Jul 2011. 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?
Twenty-four hour urinary Na/K ratio (AUC(0-24)). (time frame: 0-24hr postdose per period). 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 6 Jul 2011.