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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Metformin/CP-690,550

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Drug-Drug Interaction Healthy Volunteers CP-690, 550 Metformin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin/CP-690,550

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT01405118

First Posted

July 7, 2011

Last Updated

August 17, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01405118

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Drug-Drug Interaction Healthy Volunteers CP-690, 550 Metformin

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin/CP-690,550

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Metformin/CP-690,550

Intervention Description

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.

Primary Outcome Measure Information:

Title

AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin

Time Frame