Skip to main content
OpenTrials
Completed

NCT Number: NCT01405118

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin/CP-690,550

Drug

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 outcomes

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

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

  2. Cmax (Maximum plasma concentration) of metformin

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

  3. Clr (Renal clearance) of metformin

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

Secondary outcomes

  1. AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

  2. t½ (Terminal half-life) of metformin

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

  3. Tmax (Time for maximum plasma concentration) of metformin

    Time frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

  4. Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin

    Time frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4

  5. Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin

    Time frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4

  6. Clr (Renal clearance) over each collection interval for metformin

    Time frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4

  7. CP-690,550 plasma concentration at 2 hours postdose

    Time frame: 2 hrs after first CP-690,550 dose on Day 4

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2011
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.