HealthyPhase 1NCT00956956
A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
A Phase 1 study testing PF-04455242 in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04455242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2009to Dec 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects without childbearing potential between the ages of 21 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Placebo Controlled, Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.
- Conditions
- Healthy
- Being tested
- PF-04455242, Placebo
- Keywords
- An investigator and subject blinded (sponsor open), multiple dose, dose escalation design with PF 04455242 and matching placebo.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04455242Drug
3, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing.
PlaceboDrug
Placebo administered orally Q6 hours for 7 days of dosing.
| Study group | Role | What they receive |
|---|---|---|
| PF-04455242 treatment | Experimental | Not described Receives: Drug: PF-04455242 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
Measured: 10 days
Plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
Measured: 10 days
Secondary outcomes (1)
Effect of multiple-doses of PF 04455242 on serum prolactin concentration.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 36 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
- NCT00956956
- Sponsor's protocol ID
- B1071002
- Status last verified
- Jan 2010
- First submitted
- 10 Aug 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo Controlled, Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00956956
- Acronym / sponsor ID
- B1071002
- Conditions
- Healthy
- Keywords
- An investigator and subject blinded (sponsor open), multiple dose, dose escalation design with PF 04455242 and matching placebo.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Aug 2009 (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 goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04455242 treatment | Experimental | Drug: PF-04455242 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects without childbearing potential between the ages of 21 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
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-044552423, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing. | Drug | PF-04455242 treatment |
| PlaceboPlacebo administered orally Q6 hours for 7 days of dosing. | Drug | Placebo |
Primary outcome
Safety and tolerability of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
Time frame: 10 days
Plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
Time frame: 10 days
1 secondary outcome
Effect of multiple-doses of PF 04455242 on serum prolactin concentration.
Time frame: 10 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 7 Jan 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 PF-04455242 in people with Healthy, run by Pfizer at 1 site in Singapore.
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 1 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 7 Jan 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 Singapore. 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 ascending doses of PF 04455242 administered orally to healthy adult subjects. (time frame: 10 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 7 Jan 2010.