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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Metformin/CP-690,550

• Registration Number: NCT01405118
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-29
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin/CP-690,550	Metformin/CP-690,550	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium