Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
NCT01370343
ABOUT THIS STUDY
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- Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 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. Women must be of non childbearing potential as defined in Lifestyle Guidelines. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, sychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.
- Subjects with clinically significant infections within the past 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), or evidence of any
infection within the past 7 days.
- Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a
single measurement [confirmed by a single repeat, if necessary] following at least 5
minutes of rest.
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Descriptive Information | ||||
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Brief Title ICMJE | Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers | |||
Official Title ICMJE | A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Healthy Adult Subjects | |||
Brief Summary | The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2011 | |||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT01370343 | |||
Other Study ID Numbers ICMJE | B2611010 | |||
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 | September 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |