HealthyPhase 1NCT01934569
Drug-Drug Interaction Study With PF-05089771
A Phase 1 study testing Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This study will test the potential for PF-05089771 to interact with a cocktail of drugs Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Nov 2013
- 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 male and/or female subjects between the ages of 18 and 55 years;
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Who cannot join
- Any condition possibly affecting drug absorption
- History of regular alcohol consumption
- Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic),
- Consumption of coffee, cola or other caffeine containing drinks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates
This study will test the potential for PF-05089771 to interact with a cocktail of drugs
- Conditions
- Healthy
- Being tested
- Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771Drug
PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Active tratment | Experimental | Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771 Receives: Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 24h
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 24h
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: 24h
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 24h
Secondary outcomes (1)
Change from Baseline in Lipid Parameters
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
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 posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01934569
- Sponsor's protocol ID
- B3291023
- Status last verified
- Jan 2014
- First submitted
- 29 Aug 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates
- ClinicalTrials.gov ID
- NCT01934569
- Acronym / sponsor ID
- B3291023
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Sep 2013 (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.
This study will test the potential for PF-05089771 to interact with a cocktail of drugs
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tratment | Experimental | Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years;
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Key exclusion criteria (4 listed)
- Any condition possibly affecting drug absorption
- History of regular alcohol consumption
- Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic),
- Consumption of coffee, cola or other caffeine containing drinks
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 |
|---|---|---|
| Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose | Drug | Active tratment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 24h
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 24h
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: 24h
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 24h
1 secondary outcome
Change from Baseline in Lipid Parameters
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 16 Jan 2014.
- 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 Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 in people with Healthy, 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 4 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 16 Jan 2014. 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. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 24h). 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 16 Jan 2014.