Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

Study Overview
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Brief Summary
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This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.

Official Title
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A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Metformin/CP-690,550


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin/CP-690,550<br> | Drug: Metformin/CP-690,550<br>* Single oral 500 mg dose of metformin on Days 1 and 4 and multiple oral 30 mg doses of CP-690,550 every 12 hours on Days 2-4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 
| Cmax (Maximum plasma concentration) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 
| Clr (Renal clearance) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 
| t½ (Terminal half-life) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 
| Tmax (Time for maximum plasma concentration) of metformin |  | 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 | 
| Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin |  | 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 | 
| Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin |  | 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 | 
| Clr (Renal clearance) over each collection interval for metformin |  | 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 | 
| CP-690,550 plasma concentration at 2 hours postdose |  | 2 hrs after first CP-690,550 dose on Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Drug Interaction Healthy Volunteers CP-690, 550 Metformin