ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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);
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Drug-Drug Interaction Study With PF-05089771 | |||
Official Title ICMJE | Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates | |||
Brief Summary | This study will test the potential for PF-05089771 to interact with a cocktail of drugs | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771
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 Arms ICMJE | Experimental: Active tratment
Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771 Intervention: Drug: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 17 | |||
Original Estimated Enrollment ICMJE | 16 | |||
Actual Study Completion Date ICMJE | November 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01934569 | |||
Other Study ID Numbers ICMJE | B3291023 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |