Healthy VolunteersPhase 1NCT00812825
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
A Phase 1 study testing PF-04171327, Prednisolone and PF-04171327 Tablet in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). 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?
- PF-04171327, Prednisolone and PF-04171327 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18 and 55 years, inclusive.
- Healthy females between 18 and 44 years, inclusive.
Who cannot join
- Evidence or history of clinically significant disease;
- Post-menopausal women;
- History of intolerance or significant adverse effects with glucocorticoids. therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- PF-04171327, Prednisolone, Placebo, Placebo Solution, PF-04171327 Tablet
- Keywords
- Safety Tolerability Pharmacokinetics/pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04171327Drug
PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.
PrednisoloneDrug
Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days
PlaceboDrug
Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
Placebo SolutionDrug
Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.
PF-04171327 TabletDrug
A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.
| Study group | Role | What they receive |
|---|---|---|
| PF-04173127 | Experimental | Not described Receives: Drug: PF-04171327 |
| Prednisolone | Active comparator | Not described Receives: Drug: Prednisolone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Solution Placebo | Sham comparator | Not described Receives: Drug: Placebo Solution |
| PF-04171327 Tablet | Experimental | Not described Receives: Drug: PF-04171327 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple doses of PF-04171327
Measured: 14 days
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses
Measured: 14 days
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers
Measured: 14 days
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet
Measured: 1 day
Secondary outcomes (1)
To characterize the pharmacodynamic effects of prednisolone
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 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
- NCT00812825
- Sponsor's protocol ID
- A9391002
- Status last verified
- Aug 2009
- First submitted
- 19 Dec 2008
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00812825
- Acronym / sponsor ID
- A9391002
- Conditions
- Healthy Volunteers
- Keywords
- Safety Tolerability Pharmacokinetics/pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Dec 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 determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF-04173127 | Experimental | Drug: PF-04171327 |
| Prednisolone | Active comparator | Drug: Prednisolone |
| Placebo | Placebo comparator | Drug: Placebo |
| Solution Placebo | Sham comparator | Drug: Placebo Solution |
| PF-04171327 Tablet | Experimental | Drug: PF-04171327 Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males between 18 and 55 years, inclusive.
- Healthy females between 18 and 44 years, inclusive.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant disease;
- Post-menopausal women;
- History of intolerance or significant adverse effects with glucocorticoids. therapy.
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-04171327PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days. | Drug | PF-04173127 |
| PrednisoloneOral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days | Drug | Prednisolone |
| PlaceboTablets similar in appearance to prednisolone will be administered once daily for 14 days. | Drug | Placebo |
| Placebo SolutionPlacebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days. | Drug | Solution Placebo |
| PF-04171327 TabletA single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study. | Drug | PF-04171327 Tablet |
Primary outcome
Safety and tolerability of multiple doses of PF-04171327
Time frame: 14 days
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses
Time frame: 14 days
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers
Time frame: 14 days
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet
Time frame: 1 day
1 secondary outcome
To characterize the pharmacodynamic effects of prednisolone
Time frame: 14 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 12 Aug 2009.
- 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-04171327, Prednisolone and PF-04171327 Tablet in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
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 12 Aug 2009. 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 Belgium. 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?
Safety and tolerability of multiple doses of PF-04171327 (time frame: 14 days). 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 12 Aug 2009.