HealthyPhase 1NCT01298505
A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects
A Phase 1 study testing PF-03654764 2.5mg plus fexofenadine 60mg and PF-03654764 5mg plus fexofenadine 60mg in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine. 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-03654764 2.5mg plus fexofenadine 60mg and PF-03654764 5mg plus fexofenadine 60mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Jun 2010to 4 Jun 2010
- 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 subjects. (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, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects
The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.
- Conditions
- Healthy
- Being tested
- PF-03654764 2.5mg plus fexofenadine 60mg, PF-03654764 5mg plus fexofenadine 60mg, placebo
- Keywords
- Phase 1 multiple dose safety toleration fexofenadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03654764 2.5mg plus fexofenadine 60mgDrug
PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days
PF-03654764 5mg plus fexofenadine 60mgDrug
PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days
placeboDrug
placebo given twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| PF-03654764 2.5mg plus fexofenadine 60mg | Experimental | Not described Receives: Drug: PF-03654764 2.5mg plus fexofenadine 60mg |
| PF-03654764 5mg plus fexofenadine 60mg | Experimental | Not described Receives: Drug: PF-03654764 5mg plus fexofenadine 60mg |
| 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.
Number of participants with adverse events as a measure of safety and tolerability.
Measured: 30 days
Secondary outcomes (1)
Plasma concentrations of PF-03654764 will be measured.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study start4 Jun 2010
- Primary completion4 Jun 2010
- Study completion4 Jun 2010
Why it stopped: This study was stopped due to lack of evidence for clinical efficacy.
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)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298505
- Sponsor's protocol ID
- B0711006
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2011
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01298505
- Acronym / sponsor ID
- B0711006
- Conditions
- Healthy
- Keywords
- Phase 1 multiple dose safety toleration fexofenadine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped due to lack of evidence for clinical efficacy.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2010 (actual)
- Primary completion
- 4 Jun 2010 (actual)
- Study completion
- 4 Jun 2010 (actual)
- First posted
- 17 Feb 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.
The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-03654764 2.5mg plus fexofenadine 60mg | Experimental | Drug: PF-03654764 2.5mg plus fexofenadine 60mg |
| PF-03654764 5mg plus fexofenadine 60mg | Experimental | Drug: PF-03654764 5mg plus fexofenadine 60mg |
| 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 subjects. (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 (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
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-03654764 2.5mg plus fexofenadine 60mgPF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days | Drug | PF-03654764 2.5mg plus fexofenadine 60mg |
| PF-03654764 5mg plus fexofenadine 60mgPF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days | Drug | PF-03654764 5mg plus fexofenadine 60mg |
| placeboplacebo given twice daily for 7 days | Drug | placebo |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 30 days
1 secondary outcome
Plasma concentrations of PF-03654764 will be measured.
Time frame: 7 days
Results and safety
The study was stopped early (reason given: This study was stopped due to lack of evidence for clinical efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- 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-03654764 2.5mg plus fexofenadine 60mg and PF-03654764 5mg plus fexofenadine 60mg 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 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: stopped early, as of the sponsor's last update on 11 Feb 2019. 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 was stopped early (reason given: This study was stopped due to lack of evidence for clinical efficacy.). 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?
Number of participants with adverse events as a measure of safety and tolerability. (time frame: 30 days). 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 11 Feb 2019.