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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 metformin

Cmax (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 metformin

t½ (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

To obtain contact information for a study center near you, click here.

Starting date: June 2011
Last updated: August 17, 2011

Page last updated: August 23, 2015

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