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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01405118

Enrollment

Registered

2011-07-29

Start date

2011-06-30

Completion date

2011-07-31

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

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

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.

Interventions

DRUGMetformin/CP-690,550

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
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
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
CP-690,550 plasma concentration at 2 hours postdose	2 hrs after first CP-690,550 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
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026