Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Metformin/CP-690,550 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of
metformin, a probe drug for organic cationic transport.
Clinical Details
Official title: A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metforminCmax (Maximum plasma concentration) of metformin Clr (Renal clearance) of metformin
Secondary outcome: AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformint½ (Terminal half-life) of metformin Tmax (Time for maximum plasma concentration) of metformin Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin Clr (Renal clearance) over each collection interval for metformin CP-690,550 plasma concentration at 2 hours postdose
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult healthy male and/or female (of non child bearing potential) subjects.
Exclusion Criteria:
- Subjects with clinically significant systemic and laboratory abnormalities.
- Subjects with clinically significant infections within the past 3 months.
- Women of child-bearing potential.
Locations and Contacts
Pfizer Investigational Site, Bruxelles B-1070, Belgium
Additional Information
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Starting date: June 2011
Last updated: August 17, 2011
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